Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: BXB FDA class 1

Exerciser, Powered

Physical Medicine

View full classification →

The Exerciser, Powered is a powered physical therapy device used to provide passive or assistive exercise to patients' limbs or joints, supporting rehabilitation and maintenance of muscle function. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BXB, regulated under 21 CFR 890.5380 in the Physical Medicine specialty.

510(k) Clearances

50+ matches

K Number

Device Name

Decision Date

Decision

Applicant

K072887

G-TRAINER MEDICAL

Jan 25, 2008

Substantially Equivalent

ALTER-G, INC.

K003272

FLO-BOOT

Apr 04, 2001

Substantially Equivalent

DISCOVERY GROUP LLC.

K952975

ANKLE CALF EXERCISER PHLEBOPUMP

Sep 25, 1996

Substantially Equivalent

PREVENT PRODUCTS, INC.

K953456

E-Z FLEX

Jan 26, 1996

Substantially Equivalent

FLUID MOTION BIOTECHNOLOGIES, INC.

K955105

BTE CPM-10

Dec 29, 1995

Substantially Equivalent

BALTIMORE THERAPEUTIC EQUIPMENT CO.

K955106

BTE CPM-20

Dec 29, 1995

Substantially Equivalent

BALTIMORE THERAPEUTIC EQUIPMENT CO.

K951028

HAMEX TWO

Dec 11, 1995

Substantially Equivalent

NORTHERN ORTHOPAEDIC PRODUCTS, INC.

K950755

FLEXMATE K500

Oct 05, 1995

Substantially Equivalent

BREG, INC.

K951029

HAMEX ONE

Sep 15, 1995

Substantially Equivalent

NORTHERN ORTHOPAEDIC PRODUCTS, INC.

K945733

AQUAHAB, MODEL 120-72-101

Sep 15, 1995

Substantially Equivalent

AQUARIUS ELECTRONICS, INC.

K950682

W2 WRIST CPM UNIT

Sep 13, 1995

Substantially Equivalent

TORONTO MEDICAL CORP.

K952369

KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE

Aug 07, 1995

Substantially Equivalent

PHYSICIANS CONSULTING, INC.

K945690

BACKCYCLER CPM(TM)

Jun 22, 1995

Substantially Equivalent

ERGOMEDICS, INC.

K946169

ACTIC 2002

Jun 15, 1995

Substantially Equivalent

NORTH ATLANTIC REHABILITATION, INC,

K945824

GALAXY MD SERIES THERAPYPOOLS

Apr 05, 1995

Substantially Equivalent

GALAXY AQUATICS, INC.

K944819

KRDL 2000

Mar 10, 1995

Substantially Equivalent

PHYSICIANS CONSULTING, INC.

K945221

SUTTER MODEL 6000 HAND CPM DEVICE

Feb 27, 1995

Substantially Equivalent

SUTTER CORP.

K945121

A3 ANKLE CPM UNIT

Feb 17, 1995

Substantially Equivalent

TORONTO MEDICAL, INC.

K940455

LATERAL FLEXION MACHINE

Jan 12, 1995

Substantially Equivalent for Some Indications

REHAB, INC.

K935011

SWIMEX MULTIDEPTH POOL (MODEL 600T)

Jan 09, 1995

Substantially Equivalent

SWIMEX SYSTEMS

K935587

MULTILINK SHOULDER CPM UNIT

Dec 14, 1994

Substantially Equivalent

TORONTO MEDICAL CORP.

K935509

HYDROTRACK

Oct 03, 1994

Substantially Equivalent

FERNO ILLE

K935216

SEMI-RECUMBENT CYCLES

Sep 16, 1994

Substantially Equivalent

BIODEX MEDICAL SYSTEMS, INC.

K935061

LOWER BODY CYCLES

Sep 16, 1994

Substantially Equivalent

BIODEX MEDICAL SYSTEMS, INC.

K935520

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

Sep 16, 1994

Substantially Equivalent

BIODEX MEDICAL SYSTEMS, INC.

K933059

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

Jun 22, 1994

Substantially Equivalent

JACE SYSTEMS, INC.

K942618

ANKLE CALF EXERCISER

Jun 22, 1994

Substantially Equivalent

PREVENT PRODUCTS, INC.

K926136

WATSYSTEM

May 20, 1994

Substantially Equivalent

WATSYSTEM DIV. OF ITC

K931128

BASIC SHOULDER CPM

May 06, 1994

Substantially Equivalent

DANNINGER MEDICAL TECHNOLOGY, INC.

K935467

R & D BATTERIES, INC. PART NUMBER 5447

Apr 19, 1994

Substantially Equivalent

R & D BATTERIES, INC.

K935188

STRETCHPOWER

Mar 24, 1994

Substantially Equivalent

ORTHOPEDIC DEVELOPMENT, INC.

K934175

STRETCHPOWER(TM) BRAND OF STRETCH LOADING EXERCISER

Mar 24, 1994

Substantially Equivalent

ORTHOPEDIC DEVELOPMENT, INC.

K935808

REVOLUTION LOWER LIMB CPM UNIT

Mar 18, 1994

Substantially Equivalent

TORONTO MEDICAL, INC.

K933394

DANNIFLEX CPM 600

Mar 11, 1994

Substantially Equivalent

DANNINGER MEDICAL TECHNOLOGY, INC.

K930780

ADV400 TOE CPM

Feb 17, 1994

Substantially Equivalent

ADVANCED KINETICS, INC.

K926313

COMPUTERIZED TESTING AND EXERCISE SYSTEMS

Feb 04, 1994

Substantially Equivalent

HENLEY INTL.

K931555

ARTROMOT K2 CPM

Jan 31, 1994

Substantially Equivalent

ORMED MFG., INC.

K931736

M-FLEX 5000 C3PMD

Jan 27, 1994

Substantially Equivalent

MEDICAL SYSTEMS CORP.

K931723

HYDRO-TRED/AIR POWERED TREADMILL

Jan 26, 1994

Substantially Equivalent

SANTA FE SWIM SYSTEMS

K926262

FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE

Jan 26, 1994

Substantially Equivalent

SGARLATO LABORATORIES, INC.

K933311

MOTORIZED ELECTRIC PARALLEL BARS

Jan 26, 1994

Substantially Equivalent

MIDLAND MFG. CO.

K925270

EX N' FLEX EF-200

Jul 21, 1993

Substantially Equivalent

TECOGICS SCIENTIFIC LTD.

K925977

PARAMED FLEXION-EXTENSION MACHINE

Mar 31, 1993

Substantially Equivalent

PARAMED SERVICES, INC.

K925271

REPEX-REPEATED ENDRANGE PASSIVE EXERCISE MACHINE

Mar 31, 1993

Substantially Equivalent

REPEX INTL., INC.

K924513

LIDO(R) LINEA

Mar 31, 1993

Substantially Equivalent

LOREDAN BIOMEDICAL, INC.

K925807

AQUACISER IN-POOL TREADMILL

Mar 24, 1993

Substantially Equivalent

AQUACISER, INC.

K925926

MOBILIMB T1 TOE CPM UNIT

Mar 22, 1993

Substantially Equivalent

TORONTO MEDICAL CORP.

K924484

ARTROMOT MULTI DIRECTIONAL ANKLE CPM

Mar 22, 1993

Substantially Equivalent

BUCKMAN CO., INC.

K925666

THERAPACER 3000

Mar 09, 1993

Substantially Equivalent

KVM TECHNOLOGIES, INC.

K924654

FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT

Feb 22, 1993

Substantially Equivalent

SUTTER CORP.

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

Popular Product Codes

Commonly searched

DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump