Percussor, Powered-Electric

FDA product code BYI · 57 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.5665
Review panel: AN
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-10-28 – 2026-04-30

BYI 2026-04-30

AffloVest® Mobile Airway Clearance Therapy

Applicant Tactile Medical

K number K252849

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BYI 2025-10-02

BreatheBand® (Model 1000)

Applicant Exemplar Medical, LLC

K number K250860

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BYI 2024-12-19

LibAirty Airway Clearance System

Applicant Synchrony Medical , Ltd.

K number K242063

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BYI 2024-12-18

Respiratory Muscle Trainer

Applicant Chongqing Moffy Innovation Technology Co., Ltd.

K number K240959

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BYI 2024-03-22

The Vest APX System (PVAPX1)

Applicant Baxter Healthcare Corportation

K number K233441

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BYI 2022-11-18

Electromed SmartVest Airway Clearance System

Applicant Electromed, Inc.

K number K222496

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BYI 2021-02-12

Electro Flo 6 Airway Clearance System

Applicant Med Systems, Inc.

K number K201490

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BYI 2021-01-15

AirPhysio Positive Expiratory Pressure (PEP) Device

Applicant Airphysio Pty, Ltd.

K number K203209

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BYI 2018-10-24

Monarch Airway Clearance System

Applicant Hill-Rom Holdings, Inc.

K number K173603

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BYI 2017-03-17

Monarch Airway Clearance System

Applicant Hill-Rom Services Pte, Ltd.

K number K163378

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BYI 2013-12-19

SMARTVEST AIRWAY CLEARANCE SYSTEM

Applicant Electromed, Inc.

K number K132794

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BYI 2013-11-22

BREATH SHAKE

Applicant Cheen Houng Ent. Co. , Ltd.

K number K121587

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BYI 2013-03-27

INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST

Applicant International Biophysics Corporation

K number K122480

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BYI 2012-07-13

RESIN 11

Applicant Respinnovation Sas

K number K121170

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BYI 2011-01-26

FREQUENCER

Applicant Dymedso, Inc.

K number K103176

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BYI 2010-08-31

FREQUENCER MODEL V2X

Applicant Dymedso, Inc.

K number K100749

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BYI 2007-03-15

FREQUENCER, MODEL 1001

Applicant Dymedso, Inc.

K number K063645

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BYI 2006-06-22

LUNG FLUTE

Applicant Medical Acoustics, LLC

K number K060439

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BYI 2005-12-01

SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL

Applicant Electromed, Inc.

K number K053248

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BYI 2005-06-17

THE INCOURAGE SYSTEM

Applicant Respiratory Technologies, Incorporated

K number K051383

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BYI 2004-04-07

MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ

Applicant Electromed, Inc.

K number K040367

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BYI 2003-11-21

ELECTRO FLO PERCUSSOR, MODEL 5000

Applicant Med Systems

K number K031876

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BYI 2003-02-21

THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104

Applicant Advanced Respiratory

K number K024309

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BYI 2001-10-09

ABI VEST AIRWAY CLEARANCE SYSTEM

Applicant Advanced Respiratory

K number K012928

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BYI 2000-01-21

ABI VEST AIRWAY CLEARANCE SYSTEM

Applicant American Biosystems, Inc.

K number K993629

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BYI 1999-06-01

MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000

Applicant Electromed, Inc.

K number K982889

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BYI 1998-08-06

X-AIR-CISER

Applicant Hougen Mfg., Inc.

K number K974849

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BYI 1998-06-05

FLUTTER D

Applicant Bradstreet Clinical Research Assoc., Inc.

K number K972859

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BYI 1997-06-24

THAIRAPY VEST SYSTEM

Applicant American Biosystems, Inc.

K number K965192

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BYI 1995-03-13

FLUTTER(R)

Applicant Bradstreet Clinical Research Assoc., Inc.

K number K946083

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BYI 1994-10-28

3P (PULMONARY PERCUSSIVE PACK)

Applicant Delta Medical Manuf, Inc.

K number K931988

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BYI 1994-08-02

THAIRAPY SYSTEM

Applicant American Biosystems, Inc.

K number K936121

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BYI 1994-05-24

FLUTTER(R)

Applicant Varioraw SA

K number K940986

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BYI 1991-10-23

EMS PERCUSSOR

Applicant Engineered Medical Systems

K number K913014

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BYI 1990-03-15

MJ PERCUSSOR(TM)

Applicant Merced Medical, Inc.

K number K901026

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BYI 1989-05-25

FLEX-CUP PERCUSSOR

Applicant Life Design Systems, Inc.

K number K892862

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BYI 1989-01-04

PULMO-PATTY

Applicant Tower Stopper, Inc.

K number K882604

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BYI 1988-12-16

THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101

Applicant American Biosystems, Inc.

K number K884098

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BYI 1988-12-13

MANUAL PERCUSSOR CUPS

Applicant Medical Components, Inc.

K number K883899

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BYI 1988-03-29

THUMPER MODEL P-1000

Applicant Micro Tek Engineering

K number K880597

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BYI 1986-10-06

SALTER LABS 3000 SERIES PERCUSSORS

Applicant Salter Labs

K number K863658

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BYI 1986-02-20

NEONATE PERCUSSOR

Applicant Ballard Medical Products

K number K860510

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BYI 1986-01-23

NEOCUSSOR (MASSAGER, BATTERY) POWERED

Applicant General Physiotherapy, Inc.

K number K855129

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BYI 1985-12-03

NEOGUARD CHEST PERCUSSOR

Applicant Cas Medical Systems, Inc.

K number K853965

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BYI 1984-07-23

INFANT PERCUSSOR PA-010

Applicant Alpha Medical Systems

K number K842608

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BYI 1982-07-26

PNEUMOPULSSOR (PPS II)

Applicant Strom Corp.

K number K821265

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BYI 1982-06-03

PNEUMO PULSSOR III

Applicant Strom Corp.

K number K821570

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BYI 1981-12-29

PNEUMO PULSSOR

Applicant Strom Corp.

K number K813438

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BYI 1981-12-03

INFANT PERCUSSOR #5534

Applicant Hudson Oxygen Therapy Sales Co.

K number K812803

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BYI 1981-08-25

MJ NEONATAL PERCUSSOR

Applicant Cussionair Therapy Products, Inc.

K number K812151

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BYI 1981-08-18

PERCUSSOR

Applicant Dhd Medical Products Div. Diemolding Corp.

K number K812166

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BYI 1980-11-12

HAND PERCUSSOR CUP #65210

Applicant B & F Medical Products, Inc.

K number K802646

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BYI 1980-10-23

MODEL 2500 PNEUMATIC PERCUSSOR

Applicant Medical Equipment Development Co., Inc.

K number K802399

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BYI 1980-09-16

THE MCSHIRLEY PERCUSSOR

Applicant Mcshirley Products, Inc.

K number K801982

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BYI 1980-04-10

MJ PERCUSSOR

Applicant Cussionair Therapy Products, Inc.

K number K800713

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BYI 1979-04-18

5300 PERCUSSOR

Applicant Hudson Oxygen Therapy Sales Co.

K number K790675

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BYI 1977-10-28

ARGYLE PEOCUSSOR SYSTEM

Applicant Sherwood Medical Industries

K number K771876

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