Stimulator, Nerve, Transcutaneous, For Pain Relief

FDA product code GZJ · 599 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.5890
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-11-30 – 2026-05-28

GZJ 1991-12-10

MEDTRONIC MODEL 90002065 MF TENS SYSTEM

Applicant Medtronic Vascular

K number K911963

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GZJ 1991-11-22

TX 3 TENS MODIFIED

Applicant Globalcare/Bay Medical Corp.

K number K913532

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GZJ 1991-11-22

ULTIMA XS, MODIFICATION

Applicant American Imex

K number K912289

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GZJ 1991-11-19

RELIEF BAND (T.E.N.S. DEVICE)

Applicant Maven Labs, Inc.

K number K901704

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GZJ 1991-11-13

MICRO-Q

Applicant Quantitative Medicine, Inc.

K number K912463

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GZJ 1991-11-13

Q-TENS

Applicant Quantitative Medicine, Inc.

K number K912460

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GZJ 1991-10-25

BIO TENS 601, 606 AND 608 (3000)

Applicant Skylark Device Co., Ltd.

K number K912178

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GZJ 1991-10-15

AXION 5, MODIFICATION

Applicant Ventura Medical Electronics

K number K911814

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GZJ 1991-10-15

TEAM-MC

Applicant Henley Intl.

K number K905672

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GZJ 1991-10-04

MEDA CROWN SERIES

Applicant Medical Electronic Assn.

K number K913800

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GZJ 1991-08-28

SOLITENS MODIFIED

Applicant Innovative Designer Products, Inc.

K number K913522

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GZJ 1991-08-23

DYNEX IIIB, MODEL 89002026

Applicant Medtronic Vascular

K number K913594

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GZJ 1991-07-09

GLOBAL CARE MICRO II

Applicant Globalcare Intl., Inc.

K number K910244

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GZJ 1991-06-24

SX90 (TM),MODEL 4800S

Applicant Medical Devices, Inc.

K number K912348

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GZJ 1991-06-21

AGARRELIEF 10 TRANSCUTANEOUS ELEC NERVE STIMULATOR

Applicant Agar Ginosar Electronics

K number K905526

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GZJ 1991-06-20

MICROSTIM 100 MODEL 2C

Applicant Microstim, Inc.

K number K910580

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GZJ 1991-06-06

MY-O-MATIC 5000I

Applicant Monad Corp.

K number K902226

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GZJ 1991-06-04

ELECTRO-NERVE STIMULATOR TENS MODEL BIOMED 2000/A

Applicant Biomedical Life Systems, Inc.

K number K905570

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GZJ 1991-06-04

ELECTRO-NERVE STIMULATOR TENS MODEL SYSTEMS 2000/A

Applicant Biomedical Life Systems, Inc.

K number K905377

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GZJ 1991-06-04

ELECTRO-NEVE STIMULATOR TENS MODEL BIOMED PLUS/A

Applicant Biomedical Life Systems, Inc.

K number K905230

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GZJ 1991-06-04

POINTER F-3 TENS

Applicant Oms Medical Supplies, Inc.

K number K904388

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GZJ 1991-05-30

COM-TENS: A NEUROSTIMULATOR

Applicant Apex Medical, Inc.

K number K902102

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GZJ 1991-05-13

MENS FREEDOM MICRO

Applicant Monad Corp.

K number K904430

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GZJ 1991-05-13

MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS

Applicant Monad Corp.

K number K904288

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GZJ 1991-05-13

MENS-O-MATIC 3000

Applicant Monad Corp.

K number K904260

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GZJ 1991-05-13

MICRO DERM

Applicant Monad Corp.

K number K904258

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GZJ 1991-05-13

MENS-O-MATIC 2000

Applicant Monad Corp.

K number K904235

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GZJ 1991-05-13

MENS-O-MATIC I

Applicant Monad Corp.

K number K904234

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GZJ 1991-05-09

MODEL SW-103 SOLITANS STIMULATOR

Applicant Medical Consultants Intl. , Ltd.

K number K904264

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GZJ 1991-05-06

GLOBALCARE MICRO 11 AND MICROCARE (TENS)

Applicant Globalcare Intl., Inc.

K number K903394

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GZJ 1991-04-03

DIAL-AWAY PAIN

Applicant R.F.P., Inc.

K number K904457

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GZJ 1991-03-27

MC II (TM), MODEL 7200S

Applicant Medical Devices, Inc.

K number K903161

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GZJ 1991-03-15

DYNATRON 200 MICROCURRENT

Applicant Dynatronics Corp.

K number K903577

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GZJ 1991-01-18

SYNAPS (TM)

Applicant Henley Intl.

K number K903828

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GZJ 1991-01-02

STIMTRAC PC, CATALOG NO. 78-8510

Applicant Stimtech Products

K number K903128

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GZJ 1990-12-19

MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE

Applicant Medical Design & Manufacturing Corp.

K number K902822

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GZJ 1990-11-16

TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR

Applicant Infrasonics Corp.

K number K896825

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GZJ 1990-10-26

MEGA-TENS DUAL CHANNEL T.E.N.S.

Applicant Futuremed Div. of Future Impex Corp.

K number K903017

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GZJ 1990-09-20

QUANTUM

Applicant Stressmaster Systems, Inc.

K number K896408

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GZJ 1990-08-28

ELECTROSTIM MST

Applicant Promatek Industries, Ltd.

K number K901417

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GZJ 1990-08-14

LUMISCOPE MICRO 100

Applicant Lumiscope Co., Inc.

K number K901726

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GZJ 1990-07-30

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION

Applicant Saratoga Intl., Inc.

K number K896787

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GZJ 1990-06-22

ACUDATA INDICATENS MODEL 5XS

Applicant Acudata Software

K number K900668

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GZJ 1990-06-22

ACUDATA INDICATENS MODEL 5A

Applicant Acudata Software

K number K900596

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GZJ 1990-04-26

NEUROTENS

Applicant Henley Intl.

K number K896620

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GZJ 1990-04-10

LISS BODY STIMULATOR MODEL SBL501-M

Applicant Medical Consultants Intl. , Ltd.

K number K896226

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GZJ 1990-02-23

ALPHA-STIM CS

Applicant Electromedical Products, Inc.

K number K896948

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GZJ 1990-02-02

ELECTRO-ACUSCOPE 85

Applicant Biomedical Design Instruments

K number K883911

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GZJ 1990-01-19

MEC-I-TRON MINI, MODEL M-2

Applicant Meyer Equipment Company, Inc.

K number K895289

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GZJ 1990-01-19

REBOX II (TENS)

Applicant Rebox (Uk) , Ltd.

K number K895183

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GZJ 1990-01-09

ACUSOURCE 600 (TENS)

Applicant Microcurrent Research, Inc.

K number K895977

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GZJ 1990-01-04

K-2 TENS OR MED TENS

Applicant Oms Medical Supplies, Inc.

K number K894964

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GZJ 1989-12-08

DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S

Applicant Medical Devices, Inc.

K number K895473

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GZJ 1989-11-06

ULTIMA XS MICROCURRENT TENS

Applicant American Imex

K number K895295

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GZJ 1989-10-30

TTS2600

Applicant Henley Intl.

K number K895334

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GZJ 1989-10-30

TTS2700 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR

Applicant Henley Intl.

K number K895211

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GZJ 1989-10-30

TTS2500

Applicant Henley Intl.

K number K895166

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GZJ 1989-10-30

TTS2800

Applicant Henley Intl.

K number K895161

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GZJ 1989-10-24

ELECTRONIC PAIN RELIEVERS

Applicant Jetco of America

K number K883811

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GZJ 1989-10-12

TENZCARE STIMULATOR 6890

Applicant 3M Company

K number K891992

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GZJ 1989-09-07

ACUDATA INDICATENS MODEL 5M

Applicant Acudata Software

K number K890087

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GZJ 1989-09-06

LUMISCOPE MODEL 1000/APCC MODEL 1000

Applicant Lumiscope Co., Inc.

K number K894127

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GZJ 1989-09-06

STERLING TENS

Applicant Armstrong Industries, Inc.

K number K891118

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GZJ 1989-08-10

ZIMMER TENS

Applicant American Imex

K number K894388

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GZJ 1989-07-27

TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR

Applicant Futuremed Div. of Future Impex Corp.

K number K884972

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GZJ 1989-06-23

NSD 8CS8 - TENS DEVICE

Applicant Future Medical Products, Inc.

K number K892408

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GZJ 1989-06-06

MODIFIED MRL NEUROPROBE SYSTEM V

Applicant Medical Research Laboratories, Inc.

K number K884869

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GZJ 1989-06-01

EMPI, MODEL 489, TENS

Applicant Empi

K number K890604

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GZJ 1989-05-26

ACUDATA INDICATENS MODEL 5X

Applicant Acudata Software

K number K890088

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GZJ 1989-04-26

MICRO-STIM 200

Applicant Theri-Teck, Inc.

K number K885190

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GZJ 1989-04-24

REBUILDER BUCKET SYSTEM

Applicant Micromed, Inc.

K number K882980

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GZJ 1989-03-09

MEDIMOD(TM), MODEL 8900

Applicant Medical Devices, Inc.

K number K890705

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GZJ 1989-02-13

ULTRA 2000 (T.E.N.S.)

Applicant Maxima Intl., Inc.

K number K884833

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GZJ 1989-02-09

ANESTY 10

Applicant Nihon Medix Co., Ltd.

K number K880744

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GZJ 1988-12-16

T.E.N.S. UNIT SIGMA & TX-3

Applicant Diamond Medical Equipment, Inc.

K number K883188

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GZJ 1988-12-12

TX-7 (TENS) (IC-1107)

Applicant Oms Medical Supplies, Inc.

K number K884210

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GZJ 1988-11-16

CEFAR DUAL

Applicant Cefar Medical Products, Inc.

K number K883236

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GZJ 1988-10-13

MORGAN TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR

Applicant Morgan Associates, Inc.

K number K884032

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GZJ 1988-09-30

HEPAX (TENS)

Applicant Avl Scientific Corp.

K number K882154

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GZJ 1988-09-28

TENSTAR

Applicant Healthcheck Corp.

K number K874818

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GZJ 1988-09-22

EMPI MODEL 727,NMS

Applicant Empi

K number K882631

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GZJ 1988-09-22

MODIFIED AMANA ELECTROTHERAPEUTIC SYSTEM

Applicant Amana Medical Group

K number K875072

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GZJ 1988-09-19

ELECTROSTIMULATOR MODEL 808

Applicant Cornell Enterprises Co., Inc.

K number K880426

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GZJ 1988-08-30

ALPHA-STIM 350

Applicant Electromedical Products, Inc.

K number K881753

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GZJ 1988-08-29

MEDIPAC II EC (TM), MODEL 7900

Applicant Medical Devices, Inc.

K number K882820

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GZJ 1988-08-19

MEDA ONE-STEP

Applicant Medical Electronic Assn.

K number K882943

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GZJ 1988-08-11

INDICATENS 4X4

Applicant Acudata Software

K number K881708

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GZJ 1988-08-01

ACUTRON

Applicant Davis Assoc.

K number K880042

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GZJ 1988-07-01

DS-200 AND DS-400 T.E.N.S.

Applicant Delta Marketing, Inc.

K number K881832

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GZJ 1988-05-04

EASY TENS

Applicant American Imex

K number K881704

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GZJ 1988-04-18

INTERCEPT T.E.N.S. DEVICE

Applicant Medical Design & Manufacturing Corp.

K number K880492

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GZJ 1988-04-15

EMPI MODEL 989, TENS

Applicant Empi

K number K881114

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GZJ 1988-04-11

PREMIER 10S (TENS)

Applicant American Imex

K number K881424

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GZJ 1988-04-11

SCHULDT* PC* - DUAL CHANNEL TENS

Applicant Schuldt Laboratories, Inc.

K number K880980

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GZJ 1988-04-06

ULTIMA XS (TENS)

Applicant American Imex

K number K880751

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GZJ 1988-03-24

LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE

Applicant Lumiscope Co., Inc.

K number K880452

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GZJ 1988-01-22

AMASTIM 2000

Applicant Amatech International, Inc.

K number K872704

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GZJ 1987-12-18

MEC-I-TRON, MODEL P-1

Applicant Meyer Equipment Company, Inc.

K number K873190

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GZJ 1987-12-11

REBUILDER(TM)

Applicant Micromed, Inc.

K number K874085

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GZJ 1987-11-20

TX-4(TENS) (SIGMA TENS)

Applicant Oms Medico, Inc.

K number K874550

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