Product Code: ION FDA class 1 21 CFR 890.5370

Exerciser, Non-Measuring

Physical Medicine

A Non-Measuring Exerciser is a Physical Medicine rehabilitation device designed to provide therapeutic exercise resistance or range-of-motion training without instrumentation to measure or display exercise parameters, such as basic resistance bands, springs, or simple exercise devices used in therapeutic settings. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is ION, regulated under 21 CFR 890.5370, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.

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510(k)s

FEI Numbers

248

Registration Numbers

248

Unique Applicants

Years Active

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Basic Information

Product Code: ION
Device Class: FDA class 1
Regulation Number: 890.5370
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 43 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K120783	ABLE-X	Jun 20, 2012	Substantially Equivalent	Im-Able, Ltd.
K885343	STANDEX	May 01, 1989	Substantially Equivalent	Alt, Inc.
K851065	GRAVITY KING (DEEMED SE 87/09/18)	Jun 13, 1985	Substantially Equivalent	Unique Functional Products
K840551	MOBILIZER	Mar 23, 1984	Substantially Equivalent	Lossing Orthopedic, Inc.
K833870	KNEE WALKER	Nov 29, 1983	Substantially Equivalent	Maddak, Inc.
K833249	FITNESS	Nov 07, 1983	Substantially Equivalent	Fitness Equipment Co., Inc.
K832968	PEDAL EXERCISER	Sep 29, 1983	Substantially Equivalent	Maddak, Inc.
K831543	ADJUST. WEIGHTS-BK5171-05,10,20 BEOK	Jun 24, 1983	Substantially Equivalent	Fred Sammons, Inc.
K831538	DELUXE ADJUST-ANGLE BOARD-BK4066	Jun 08, 1983	Substantially Equivalent	Fred Sammons, Inc.
K831033	GIREX	Apr 27, 1983	Substantially Equivalent	Lancer Assoc.
K830560	EXERCISER, PASSIVE, NON MEASURING	Mar 09, 1983	Substantially Equivalent	Kaye Products, Inc.
K830400	MADDATRAINER HAND EXERCISER	Mar 09, 1983	Substantially Equivalent	Maddak, Inc.
K823236	BACK ON TRACK INVERSION THERAPY & EXER	Jan 21, 1983	Substantially Equivalent	Lossing Orthopedic, Inc.
K823623	INFLATABLE HEAVY PLASTIC EXERCISER	Dec 28, 1982	Substantially Equivalent	Fred Sammons, Inc.
K823620	PLASTIC ELASTOMER IN CUBE FORM EXERCISE	Dec 22, 1982	Substantially Equivalent	Fred Sammons, Inc.
K823619	PLASTIC ELASTOMER ENCASED IN TERRY CLOTH	Dec 22, 1982	Substantially Equivalent	Fred Sammons, Inc.
K823618	PROGRESSIVE RESISTANCE EXERCISE CUFF	Dec 22, 1982	Substantially Equivalent	Fred Sammons, Inc.
K822906	PHYSICAL MEDICINE & REHABILITATION EQUIP	Oct 15, 1982	Substantially Equivalent	I-Rep, Inc.
K821857	BK-5305 MULTIPLE HAND GRID	Jul 02, 1982	Substantially Equivalent	Fred Sammons, Inc.
K821855	VISCO HANDEX-VARIOUS MODELS	Jul 02, 1982	Substantially Equivalent	Fred Sammons, Inc.
K813633	MODELING COMPOUND AND FOAM EXERCISER	Jan 19, 1982	Substantially Equivalent	Fred Sammons, Inc.
K813099	BACK RIE	Nov 24, 1981	Substantially Equivalent	Back Rite
K812474	BABY WALKER W/TOY CHEST	Sep 14, 1981	Substantially Equivalent	Maddak, Inc.
K812351	NON-MEASURING EXERCISERS	Sep 14, 1981	Substantially Equivalent	Fred Sammons, Inc.
K810444	NON-MEASURING EXERCISERS	Mar 04, 1981	Substantially Equivalent	Fred Sammons, Inc.
K801710	BK-5315-01 FOAM HAND EXERCISER, SMALL	Aug 07, 1980	Substantially Equivalent	Fred Sammons, Inc.
K801453	FINGER, HAND & WRIST EXERCISER	Aug 04, 1980	Substantially Equivalent	Robert W. Slack
K792642	THE VARIABLE LOAD KENETIC ENERGIZER	Jan 28, 1980	Substantially Equivalent	W.F. Pogue
K800017	COLOR CODED PUTTY SOFT, REGULAR & FIRM	Jan 21, 1980	Substantially Equivalent	Fred Sammons, Inc.
K790572	LOUNGE, TILT-A-BODY STRETCH	Apr 10, 1979	Substantially Equivalent	Innovative Products, Inc.
K790530	PUSH BALL INCLINE	Apr 03, 1979	Substantially Equivalent	Maddak, Inc.
K790191	VISA-GRIP	Feb 08, 1979	Substantially Equivalent	Premier Sundries, Inc.
K781350	OBJECTS PRECISION HANDLING TEST KIT	Oct 17, 1978	Substantially Equivalent	Metro. Hospital & Health Center
K772404	FINGER EXERCISE BOARD	Feb 13, 1978	Substantially Equivalent	Fred Sammons, Inc.
K770658	EXERCISER, LEG, LOWER EXTREMITY	Jun 17, 1977	Substantially Equivalent	Robert R. Moore
K770436	EXERCISER, EXTENSOR WAND	Apr 06, 1977	Substantially Equivalent	Maddak, Inc.
K770144	RHEUMATOID HAND GYM	Jan 28, 1977	Substantially Equivalent	Maddak, Inc.
K761314	FLEXION-BRAKING KNEE-SHIN ASSEMBLY	Jan 10, 1977	Substantially Equivalent	Hosmer Dorrance Corp.
K761313	4-BAR KNEE-SHIN SET-UP	Jan 10, 1977	Substantially Equivalent	Hosmer Dorrance Corp.
K761135	SHORT INFLATED ROLLS	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.
K761120	SPIN-A-PULL	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.
K760305	BALLOONS, BK-8112, 8114	Sep 08, 1976	Substantially Equivalent	Fred Sammons, Inc.
K760304	CANOPY, PARACHUTE, BK-8110	Sep 08, 1976	Substantially Equivalent	Fred Sammons, Inc.