Product Code: BXB FDA class 1 21 CFR 890.5380

Exerciser, Powered

Physical Medicine

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.

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510(k)s

160

FEI Numbers

113

Registration Numbers

113

Unique Applicants

Years Active

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Basic Information

Product Code: BXB
Device Class: FDA class 1
Regulation Number: 890.5380
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 160 510(k) clearances via K numbers.

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.
K955106	BTE CPM-20	Dec 29, 1995	Substantially Equivalent	Baltimore Therapeutic Equipment Co.
K955105	BTE CPM-10	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
K935520	UPPER BODY CYCLES (110 VOLT)/(220 VOLT)	Sep 16, 1994	Substantially Equivalent	Biodex Medical Systems, Inc.
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.
K942618	ANKLE CALF EXERCISER	Jun 22, 1994	Substantially Equivalent	Prevent Products, Inc.
K933059	ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD.	Jun 22, 1994	Substantially Equivalent	Jace Systems, 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.
K933311	MOTORIZED ELECTRIC PARALLEL BARS	Jan 26, 1994	Substantially Equivalent	Midland Mfg. Co.
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.
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.
K925043	ELBOW CPM ORTHOSIS	Feb 12, 1993	Substantially Equivalent	Electrobionics Corp.
K923857	ARTROMOT SB ELBOW ATTACHMENT	Feb 12, 1993	Substantially Equivalent	Buckman Co., Inc.
K923805	POWER PILLOW	Feb 12, 1993	Substantially Equivalent	Nova Teknic, Inc.
K923494	PARAMED LATERAL FLEXION MACHINE	Nov 09, 1992	Substantially Equivalent	Paramed Div
K921348	OIC MODEL J4 TMJ CPM	Aug 05, 1992	Substantially Equivalent	Lm Product Design, Inc.
K923217	DANNIFLEX CPM 2000	Aug 03, 1992	Substantially Equivalent	Buckman Co., Inc.
K923216	DANNINFLEX CPM 800	Aug 03, 1992	Substantially Equivalent	Buckman Co., Inc.
K922493	AMERICAN MEDICAL MFG. LUMBAR CPM	Jul 27, 1992	Substantially Equivalent	American Medical Corp.
K922185	JACE KNEE EXTENSION SYSTEM -- MODIFICATION	Jun 11, 1992	Substantially Equivalent	Jace Systems, Inc.
K920686	ORTHO-PLEX-REHABILITATION SYSTEM	Jun 11, 1992	Substantially Equivalent	Plexus Intl., Inc.
K921323	CERVICAL PASSIVE MOTION	Jun 03, 1992	Substantially Equivalent	Rehabilitative Resources, Inc.
K920860	CONTROLLED PASSIVE MOTION MACHINE	Apr 02, 1992	Substantially Equivalent	U.S. Mfg. & Management, Inc.
K920519	LUMBAR CPM	Mar 13, 1992	Substantially Equivalent	Rehabilitative Resources, Inc.
K920270	CONTINUOUS PASSIVE MOTION MODALITY ACCESSORY	Mar 02, 1992	Substantially Equivalent	Sports Medical Synergy
K920380	JACE MODEL W550 WRIST CPM DEVICE	Feb 11, 1992	Substantially Equivalent	Jace Systems, Inc.
K914860	SUTTER MODEL 10000 LEG CPM DEVICE	Jan 08, 1992	Substantially Equivalent	Sutter Corp.
K914394	BACK MASTER	Nov 13, 1991	Substantially Equivalent	Progressive Electrical Therapeutics
K913227	JACE MODEL T300 TOE CPM DEVICE	Aug 16, 1991	Substantially Equivalent	Thera Kinetics, Inc.
K912537	JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION	Aug 16, 1991	Substantially Equivalent	Thera Kinetics, Inc.
K912086	FMA TRANSLATOR	Aug 07, 1991	Substantially Equivalent	Normandie Group, Inc.
K904963	EXTEND TRACK UNIT	Jun 28, 1991	Substantially Equivalent	Anthony Chiropractic Clinic, Inc.
K905718	ROMFLEX	Feb 19, 1991	Substantially Equivalent	Paraflex Corp.
K904735	DANNIFLEX MODEL 500TM CPM	Jan 30, 1991	Substantially Equivalent	Buckman Co., Inc.
K910150	ROMFLEX REHAB EQUIP EXTREMITIES UNIT	Jan 23, 1991	Substantially Equivalent	Dyna Flex, Intl.
K910151	ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT	Jan 18, 1991	Substantially Equivalent	Dyna Flex, Intl.
K910149	ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT	Jan 18, 1991	Substantially Equivalent	Dyna Flex, Intl.
K910026	ATI MEDICAL COMFORT PLUS CPM PAD	Jan 18, 1991	Substantially Equivalent	Ati Medical, Inc.
K905299	ROMFLEX REHABILITATION EQUIPMENT	Dec 31, 1990	Substantially Equivalent	Dyna Flex, Intl.
K893924	MOTO-MED RF-II AND PICO	Nov 27, 1990	Substantially Equivalent	Holl Meditronics, Inc.
K903851	CLUB FOOT CPM MACHINE	Oct 19, 1990	Substantially Equivalent	Smith & Nephew Richards, Inc.
K903467	JACE MODEL 100 KNEE CPM DEVICE	Aug 10, 1990	Substantially Equivalent	Thera Kinetics, Inc.
K902707	MODEL 9000 AT ANKLE CPM DEVICE	Jul 25, 1990	Substantially Equivalent	Sutter Corp.
K902452	CONTINUOUS PASSIVE MOTION (CPM) LEG EXERCISER	Jun 11, 1990	Substantially Equivalent	Berner Assoc., Inc.
K900795	MOBILIMB L4 LOWER LIMB CPM UNIT	Mar 12, 1990	Substantially Equivalent	Toronto Medical Corp.
K900466	MOBILIMB W1 WRIST CPM UNIT	Mar 12, 1990	Substantially Equivalent	Toronto Medical Corp.
K895720	MOBILIMB J1 TMJ CPM UNIT	Jan 04, 1990	Substantially Equivalent	Toronto Medical Corp.
K894907	MARK IV HAND, THUMB AND WRIST (CPM) UNIT	Oct 06, 1989	Substantially Equivalent	Innovative Medical Engineering, Inc.
K895015	ARTROMOT(TM) CPM DEVICES	Sep 11, 1989	Substantially Equivalent	Buckman Co., Inc.
K891345	MOBILIMB CPM SHOULDER UNIT	Apr 24, 1989	Substantially Equivalent	Toronto Medical Corp.
K890838	REHABOT-YM	Mar 23, 1989	Substantially Equivalent	Imex Health, Inc.
K885182	TOTAL KNEE CPM	Mar 15, 1989	Substantially Equivalent	Invacare Corp.
K890607	SUTTER HOSPITAL CPM	Feb 27, 1989	Substantially Equivalent	Sutter Corp.
K885095	SUPREME TONING SYSTEMS	Feb 06, 1989	Substantially Equivalent	Supreme Toning Systems
K890200	PNEUMATIC DORSIFLEXOR	Feb 03, 1989	Substantially Equivalent	Medical Flotation Systems, Inc.
K881314	PROMO-RIST C.P.M.	Jan 13, 1989	Substantially Equivalent	Professional Motion, Inc.
K882406	CONVA-LIFT	Nov 30, 1988	Substantially Equivalent	Numerical Concepts, Inc.
K882916	MOTORIZED PARALLEL BAR, MODEL 110	Jul 28, 1988	Substantially Equivalent	Tri W-G, Inc.
K880865	RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300	May 02, 1988	Substantially Equivalent	Invacare Corp.
K873658	ANKLE REFLEX TREATMENT UNIT (ARTU)	Apr 21, 1988	Substantially Equivalent	Universal Gym Equipment, Inc.
K880092	RESUBMITTED FITNESS UPPER BODY ERGOMETER #5100	Apr 11, 1988	Substantially Equivalent	Invacare Corp.
K874884	MEDTRONIC(R) ORTHOFLEX(TM)	Jan 28, 1988	Substantially Equivalent	Metronic, Inc.
K872815	TRANSJAW(TM)	Jan 19, 1988	Substantially Equivalent	Vitek, Inc.
K874196	POWER EXERCISE EQUIPMENT	Dec 10, 1987	Substantially Equivalent	Arc Motion , Ltd.
K872639	DELUXE MOTORIZED TREADMILL MODEL #FT2300	Sep 18, 1987	Substantially Equivalent	Invacare Corp.
K872638	MOTORIZED TREADMILL MODEL #FT2200	Sep 18, 1987	Substantially Equivalent	Invacare Corp.
K872586	ERGOMETRIC MOTORIZED TREADMILL MODEL #FT2400	Sep 18, 1987	Substantially Equivalent	Invacare Corp.
K871981	BILATERAL CONTINUOUS PASSIVE MOTION DEVICE	Jun 17, 1987	Substantially Equivalent	Avec Scientific Design Corp.
K871012	CONTINUOUS PASSIVE MOTION PATIENT KIT OR RE. PAD	Mar 25, 1987	Substantially Equivalent	Cropper Medical, Inc.
K870402	MOBILIMB HAND EXERCISER	Mar 16, 1987	Substantially Equivalent	Biodynamic Technologies, Inc.
K870510	DANNIFLEX 400I	Feb 26, 1987	Substantially Equivalent	Buckman Co., Inc.
K864427	KNEECPM	Dec 02, 1986	Substantially Equivalent	Invacare Corp.
K863639	ARTICULAR MOTION DEVICE (AMD4000)	Sep 29, 1986	Substantially Equivalent	Med Surg Designs, Inc.
K862730	DANNIFLEX 400SL	Jul 24, 1986	Substantially Equivalent	Danninger Medical Technology, Inc.
K862093	GINGERBREAD MAN (TM)	Jul 22, 1986	Substantially Equivalent	Southern Pride Manufacturing, Inc.
K862314	HIP CONTINUOUS PASSIVE MOTION MACHINE	Jul 15, 1986	Substantially Equivalent	Richards Medical Co., Inc.
K854354	THE BLEDSOE PASSIVE MOTION EXERCISER	Feb 06, 1986	Substantially Equivalent	Medical Technology and Innovations, Inc.
K852977	KNEE MACHINE	Oct 16, 1985	Substantially Equivalent	Kaiser Medical
K852399	TOTAL CPM	Aug 09, 1985	Substantially Equivalent	Invacare Corp.
K852065	PRESTON LOWER LIMB CPM UNIT	Jul 19, 1985	Substantially Equivalent	Therapeutic Equipment Corp.
K851331	EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT)	Jul 17, 1985	Substantially Equivalent	Empi
K851177	UNIVERSAL POWER FLEX	Jun 28, 1985	Substantially Equivalent	Biodynamic Technologies, Inc.
K844779	HEALTHMASTER- MODEL 8320 MOTORIZED TREADMILL	Jun 28, 1985	Substantially Equivalent	Roadmaster Corp.
K850871	TREDBAND TYPE I, IT, II & III - TREADMILLS	Jun 05, 1985	Substantially Equivalent	Ketronic, Inc.
K844118	THERAPEUTIC LIMB MANIPULATOR	May 17, 1985	Substantially Equivalent	Donald E. Redding
K850332	KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE	May 01, 1985	Substantially Equivalent	Richards Medical Co., Inc.
K850274	SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENT	Apr 25, 1985	Substantially Equivalent	Sutter Biomedical, Inc.
K850030	CONCENTRICAL CONTINUOUS PASSIVE MOTION MACHINE	Apr 25, 1985	Substantially Equivalent	Arc Motion , Ltd.
K844995	SYNCHRO-LINK -CONTIN-PASSIVE MOTION DEVICE/MUSCLE	Apr 01, 1985	Substantially Equivalent	Cropper Medical, Inc.
K843309	UNIFLEX DANNINGER	Oct 16, 1984	Substantially Equivalent	Buckman Co., Inc.
K843493	PATIENT GUIDED KNEE EXERCISER	Sep 12, 1984	Substantially Equivalent	Richards Medical Co., Inc.
K842882	ANKLE MOBILIZER	Aug 08, 1984	Substantially Equivalent	Joint Mobilizer Systems, Inc.
K842881	KNEE-HIP MOBILIZER	Aug 08, 1984	Substantially Equivalent	Joint Mobilizer Systems, Inc.
K842433	ALLIED ASSOC. THERAPEUTIC EXERCISE	Aug 02, 1984	Substantially Equivalent	Allied Associates, Inc.
K842430	ALLIED ASSOC. THERAP. EXERCISE EQUIP	Aug 02, 1984	Substantially Equivalent	Allied Associates, Inc.
K842429	ALLIED ASSOC. THERAPEUTIC EXER EQUIP-	Aug 02, 1984	Substantially Equivalent	Allied Associates, Inc.
K842432	ALLIED ASSOCIATES THERAPEUTIC EXERSIE	Aug 01, 1984	Substantially Equivalent	Allied Associates, Inc.
K842431	ALLIED ASSOC. THERAP. EXERCISE EQUIP-	Aug 01, 1984	Substantially Equivalent	Allied Associates, Inc.
K842428	ALLIED ASSOC. THERAPEUTIC EXERCICE EQUIP	Aug 01, 1984	Substantially Equivalent	Allied Associates, Inc.
K842427	ALLIED ASSOC. THERAPEUTIC EXERCISE EQUIP	Aug 01, 1984	Substantially Equivalent	Allied Associates, Inc.
K842426	ALLIED ASSOC. THERAPEUTIC EXERICSE	Aug 01, 1984	Substantially Equivalent	Allied Associates, Inc.
K842425	ALLIED ASSOCIATES THERAPEUTIC EXERCISE	Aug 01, 1984	Substantially Equivalent	Allied Associates, Inc.
K841674	CONTINUOUS PASSIVE MOTION	May 09, 1984	Substantially Equivalent	Chattanooga Group, Inc.
K841413	HYDRA-GYM ATHLETICS INC.	Apr 18, 1984	Substantially Equivalent	Hydra Fitness Industries
K834203	FLEXXR* CPM SYSTEM	Jan 30, 1984	Substantially Equivalent	Qarex Laboratories, Inc.
K831910	STRYKER LEG EXERCISER	Jul 12, 1983	Substantially Equivalent	Stryker Corp.
K830793	PATIENT GUIDED ELBOW & SHOULDER EXERC	Jun 16, 1983	Substantially Equivalent	Richard'S Medical Equip., Inc.
K830316	UNIFLEX	Mar 24, 1983	Substantially Equivalent	Buckman Consultants
K830649	SUTTER CPM 2000	Mar 17, 1983	Substantially Equivalent	Sutter Biomedical, Inc.
K830369	POWER FLEX	Mar 08, 1983	Substantially Equivalent	Biodynamic Technologies of Florida
K830122	CONTINUOUS ANATOMICAL PASSIVE EXERCISER	Feb 07, 1983	Substantially Equivalent	Zimmer, Inc.
K823495	MOBILIMB-CPM UPPER/LOWER LIMB DEVICE	Jan 21, 1983	Substantially Equivalent	Synthes (Usa)
K823539	SUTTER CPM	Jan 14, 1983	Substantially Equivalent	Sutter Biomedical, Inc.
K822212	MOTORIZED EXERCISER	Aug 31, 1982	Substantially Equivalent	W.R. Mccullin
K822031	AUTORANGE MODEL 205	Jul 26, 1982	Substantially Equivalent	Tri W-G, Inc.
K821016	QUADRUPLE JOGGER EXERCISER	Apr 26, 1982	Substantially Equivalent	Industrial Energy Specialists, Inc.
K820476	KEM-2	Mar 08, 1982	Substantially Equivalent	Medical Graphics Corp.
K820120	PATIENT GUIDED KNEE EXERCISER	Jan 29, 1982	Substantially Equivalent	Richard'S Medical Equip., Inc.
K820083	SUTTER CPM	Jan 28, 1982	Substantially Equivalent	Sutter Biomedical, Inc.
K810238	SUPINE STRESS SYSTEM	Feb 13, 1981	Substantially Equivalent	O'Neill
K800007	WORK SIMULATOR	Jan 21, 1980	Substantially Equivalent	Baltimore Therapeutic Equipment Co.