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Exerciser, Powered

FDA product code BXB · 160 cleared devices

Class 1 Physical Medicine

Regulation: 21 CFR 890.5380
Review panel: PM
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1980-01-21 – 2008-01-25

BXB 2008-01-25

G-TRAINER MEDICAL

Applicant Alter-G, Inc.

K number K072887

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BXB 2001-04-04

FLO-BOOT

Applicant Discovery Group, LLC

K number K003272

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BXB 1996-09-25

ANKLE CALF EXERCISER PHLEBOPUMP

Applicant Prevent Products, Inc.

K number K952975

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BXB 1996-01-26

E-Z FLEX

Applicant Fluid Motion Biotechnologies, Inc.

K number K953456

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BXB 1995-12-29

BTE CPM-20

Applicant Baltimore Therapeutic Equipment Co.

K number K955106

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BXB 1995-12-29

BTE CPM-10

Applicant Baltimore Therapeutic Equipment Co.

K number K955105

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BXB 1995-12-11

HAMEX TWO

Applicant Northern Orthopaedic Products, Inc.

K number K951028

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BXB 1995-10-05

FLEXMATE K500

Applicant Breg, Inc.

K number K950755

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BXB 1995-09-15

HAMEX ONE

Applicant Northern Orthopaedic Products, Inc.

K number K951029

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BXB 1995-09-15

AQUAHAB, MODEL 120-72-101

Applicant Aquarius Electronics, Inc.

K number K945733

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BXB 1995-09-13

W2 WRIST CPM UNIT

Applicant Toronto Medical Corp.

K number K950682

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BXB 1995-08-07

KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE

Applicant Physicians Consulting, Inc.

K number K952369

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BXB 1995-06-22

BACKCYCLER CPM(TM)

Applicant Ergomedics, Inc.

K number K945690

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BXB 1995-06-15

ACTIC 2002

Applicant North Atlantic Rehabilitation, Inc.

K number K946169

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BXB 1995-04-05

GALAXY MD SERIES THERAPYPOOLS

Applicant Galaxy Aquatics, Inc.

K number K945824

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BXB 1995-03-10

KRDL 2000

Applicant Physicians Consulting, Inc.

K number K944819

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BXB 1995-02-27

SUTTER MODEL 6000 HAND CPM DEVICE

Applicant Sutter Corp.

K number K945221

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BXB 1995-02-17

A3 ANKLE CPM UNIT

Applicant Toronto Medical, Inc.

K number K945121

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BXB 1995-01-12

LATERAL FLEXION MACHINE

Applicant Rehab, Inc.

K number K940455

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BXB 1995-01-09

SWIMEX MULTIDEPTH POOL (MODEL 600T)

Applicant Swimex Systems

K number K935011

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BXB 1994-12-14

MULTILINK SHOULDER CPM UNIT

Applicant Toronto Medical Corp.

K number K935587

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BXB 1994-10-03

HYDROTRACK

Applicant Ferno Ille

K number K935509

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BXB 1994-09-16

UPPER BODY CYCLES (110 VOLT)/(220 VOLT)

Applicant Biodex Medical Systems, Inc.

K number K935520

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BXB 1994-09-16

SEMI-RECUMBENT CYCLES

Applicant Biodex Medical Systems, Inc.

K number K935216

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BXB 1994-09-16

LOWER BODY CYCLES

Applicant Biodex Medical Systems, Inc.

K number K935061

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BXB 1994-06-22

ANKLE CALF EXERCISER

Applicant Prevent Products, Inc.

K number K942618

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BXB 1994-06-22

ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD.

Applicant Jace Systems, Inc.

K number K933059

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BXB 1994-05-20

WATSYSTEM

Applicant Watsystem Div. of Itc

K number K926136

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BXB 1994-05-06

BASIC SHOULDER CPM

Applicant Danninger Medical Technology, Inc.

K number K931128

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BXB 1994-04-19

R & D BATTERIES, INC. PART NUMBER 5447

Applicant R & D Batteries, Inc.

K number K935467

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BXB 1994-03-24

STRETCHPOWER

Applicant Orthopedic Development, Inc.

K number K935188

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BXB 1994-03-24

STRETCHPOWER(TM) BRAND OF STRETCH LOADING EXERCISER

Applicant Orthopedic Development, Inc.

K number K934175

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BXB 1994-03-18

REVOLUTION LOWER LIMB CPM UNIT

Applicant Toronto Medical, Inc.

K number K935808

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BXB 1994-03-11

DANNIFLEX CPM 600

Applicant Danninger Medical Technology, Inc.

K number K933394

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BXB 1994-02-17

ADV400 TOE CPM

Applicant Advanced Kinetics, Inc.

K number K930780

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BXB 1994-02-04

COMPUTERIZED TESTING AND EXERCISE SYSTEMS

Applicant Henley Intl.

K number K926313

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BXB 1994-01-31

ARTROMOT K2 CPM

Applicant Ormed Mfg., Inc.

K number K931555

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BXB 1994-01-27

M-FLEX 5000 C3PMD

Applicant Medical Systems Corp.

K number K931736

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BXB 1994-01-26

MOTORIZED ELECTRIC PARALLEL BARS

Applicant Midland Mfg. Co.

K number K933311

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BXB 1994-01-26

HYDRO-TRED/AIR POWERED TREADMILL

Applicant Santa FE Swim Systems

K number K931723

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BXB 1994-01-26

FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE

Applicant Sgarlato Laboratories, Inc.

K number K926262

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BXB 1993-07-21

EX N' FLEX EF-200

Applicant Tecogics Scientific , Ltd.

K number K925270

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BXB 1993-03-31

PARAMED FLEXION-EXTENSION MACHINE

Applicant Paramed Services, Inc.

K number K925977

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BXB 1993-03-31

REPEX-REPEATED ENDRANGE PASSIVE EXERCISE MACHINE

Applicant Repex Intl., Inc.

K number K925271

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BXB 1993-03-31

LIDO(R) LINEA

Applicant Loredan Biomedical, Inc.

K number K924513

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BXB 1993-03-24

AQUACISER IN-POOL TREADMILL

Applicant Aquaciser, Inc.

K number K925807

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BXB 1993-03-22

MOBILIMB T1 TOE CPM UNIT

Applicant Toronto Medical Corp.

K number K925926

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BXB 1993-03-22

ARTROMOT MULTI DIRECTIONAL ANKLE CPM

Applicant Buckman Co., Inc.

K number K924484

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BXB 1993-03-09

THERAPACER 3000

Applicant Kvm Technologies, Inc.

K number K925666

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BXB 1993-02-22

FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT

Applicant Sutter Corp.

K number K924654

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BXB 1993-02-12

ELBOW CPM ORTHOSIS

Applicant Electrobionics Corp.

K number K925043

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BXB 1993-02-12

ARTROMOT SB ELBOW ATTACHMENT

Applicant Buckman Co., Inc.

K number K923857

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BXB 1993-02-12

POWER PILLOW

Applicant Nova Teknic, Inc.

K number K923805

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BXB 1992-11-09

PARAMED LATERAL FLEXION MACHINE

Applicant Paramed Div

K number K923494

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BXB 1992-08-05

OIC MODEL J4 TMJ CPM

Applicant Lm Product Design, Inc.

K number K921348

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BXB 1992-08-03

DANNIFLEX CPM 2000

Applicant Buckman Co., Inc.

K number K923217

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BXB 1992-08-03

DANNINFLEX CPM 800

Applicant Buckman Co., Inc.

K number K923216

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BXB 1992-07-27

AMERICAN MEDICAL MFG. LUMBAR CPM

Applicant American Medical Corp.

K number K922493

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BXB 1992-06-11

JACE KNEE EXTENSION SYSTEM -- MODIFICATION

Applicant Jace Systems, Inc.

K number K922185

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BXB 1992-06-11

ORTHO-PLEX-REHABILITATION SYSTEM

Applicant Plexus Intl., Inc.

K number K920686

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BXB 1992-06-03

CERVICAL PASSIVE MOTION

Applicant Rehabilitative Resources, Inc.

K number K921323

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BXB 1992-04-02

CONTROLLED PASSIVE MOTION MACHINE

Applicant U.S. Mfg. & Management, Inc.

K number K920860

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BXB 1992-03-13

LUMBAR CPM

Applicant Rehabilitative Resources, Inc.

K number K920519

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BXB 1992-03-02

CONTINUOUS PASSIVE MOTION MODALITY ACCESSORY

Applicant Sports Medical Synergy

K number K920270

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BXB 1992-02-11

JACE MODEL W550 WRIST CPM DEVICE

Applicant Jace Systems, Inc.

K number K920380

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BXB 1992-01-08

SUTTER MODEL 10000 LEG CPM DEVICE

Applicant Sutter Corp.

K number K914860

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BXB 1991-11-13

BACK MASTER

Applicant Progressive Electrical Therapeutics

K number K914394

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BXB 1991-08-16

JACE MODEL T300 TOE CPM DEVICE

Applicant Thera Kinetics, Inc.

K number K913227

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BXB 1991-08-16

JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION

Applicant Thera Kinetics, Inc.

K number K912537

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BXB 1991-08-07

FMA TRANSLATOR

Applicant Normandie Group, Inc.

K number K912086

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BXB 1991-06-28

EXTEND TRACK UNIT

Applicant Anthony Chiropractic Clinic, Inc.

K number K904963

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BXB 1991-02-19

ROMFLEX

Applicant Paraflex Corp.

K number K905718

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BXB 1991-01-30

DANNIFLEX MODEL 500TM CPM

Applicant Buckman Co., Inc.

K number K904735

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BXB 1991-01-23

ROMFLEX REHAB EQUIP EXTREMITIES UNIT

Applicant Dyna Flex, Intl.

K number K910150

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BXB 1991-01-18

ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT

Applicant Dyna Flex, Intl.

K number K910151

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BXB 1991-01-18

ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT

Applicant Dyna Flex, Intl.

K number K910149

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BXB 1991-01-18

ATI MEDICAL COMFORT PLUS CPM PAD

Applicant Ati Medical, Inc.

K number K910026

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BXB 1990-12-31

ROMFLEX REHABILITATION EQUIPMENT

Applicant Dyna Flex, Intl.

K number K905299

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BXB 1990-11-27

MOTO-MED RF-II AND PICO

Applicant Holl Meditronics, Inc.

K number K893924

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BXB 1990-10-19

CLUB FOOT CPM MACHINE

Applicant Smith & Nephew Richards, Inc.

K number K903851

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BXB 1990-08-10

JACE MODEL 100 KNEE CPM DEVICE

Applicant Thera Kinetics, Inc.

K number K903467

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BXB 1990-07-25

MODEL 9000 AT ANKLE CPM DEVICE

Applicant Sutter Corp.

K number K902707

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BXB 1990-06-11

CONTINUOUS PASSIVE MOTION (CPM) LEG EXERCISER

Applicant Berner Assoc., Inc.

K number K902452

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BXB 1990-03-12

MOBILIMB L4 LOWER LIMB CPM UNIT

Applicant Toronto Medical Corp.

K number K900795

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BXB 1990-03-12

MOBILIMB W1 WRIST CPM UNIT

Applicant Toronto Medical Corp.

K number K900466

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BXB 1990-01-04

MOBILIMB J1 TMJ CPM UNIT

Applicant Toronto Medical Corp.

K number K895720

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BXB 1989-10-06

MARK IV HAND, THUMB AND WRIST (CPM) UNIT

Applicant Innovative Medical Engineering, Inc.

K number K894907

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BXB 1989-09-11

ARTROMOT(TM) CPM DEVICES

Applicant Buckman Co., Inc.

K number K895015

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BXB 1989-04-24

MOBILIMB CPM SHOULDER UNIT

Applicant Toronto Medical Corp.

K number K891345

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BXB 1989-03-23

REHABOT-YM

Applicant Imex Health, Inc.

K number K890838

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BXB 1989-03-15

TOTAL KNEE CPM

Applicant Invacare Corp.

K number K885182

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BXB 1989-02-27

SUTTER HOSPITAL CPM

Applicant Sutter Corp.

K number K890607

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BXB 1989-02-06

SUPREME TONING SYSTEMS

Applicant Supreme Toning Systems

K number K885095

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BXB 1989-02-03

PNEUMATIC DORSIFLEXOR

Applicant Medical Flotation Systems, Inc.

K number K890200

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BXB 1989-01-13

PROMO-RIST C.P.M.

Applicant Professional Motion, Inc.

K number K881314

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BXB 1988-11-30

CONVA-LIFT

Applicant Numerical Concepts, Inc.

K number K882406

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BXB 1988-07-28

MOTORIZED PARALLEL BAR, MODEL 110

Applicant Tri W-G, Inc.

K number K882916

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BXB 1988-05-02

RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300

Applicant Invacare Corp.

K number K880865

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BXB 1988-04-21

ANKLE REFLEX TREATMENT UNIT (ARTU)

Applicant Universal Gym Equipment, Inc.

K number K873658

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BXB 1988-04-11

RESUBMITTED FITNESS UPPER BODY ERGOMETER #5100

Applicant Invacare Corp.

K number K880092

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