Product Code: INN FDA class 1 21 CFR 890.3100

Chair, Adjustable, Mechanical

Physical Medicine

A Mechanical Adjustable Chair is a manually adjustable clinical or rehabilitation seating device used in Physical Medicine that allows modification of seat height, backrest angle, or leg support position to accommodate different patient sizes, postures, or therapeutic needs. 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 INN, regulated under 21 CFR 890.3100, within the Physical Medicine medical specialty.

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510(k)s

FEI Numbers

136

Registration Numbers

136

Unique Applicants

Years Active

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Basic Information

Product Code: INN
Device Class: FDA class 1
Regulation Number: 890.3100
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 26 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K945650	SPIFFY	Dec 19, 1994	Substantially Equivalent	Thames Valley Children'S Centre
K942397	THERADAPT HIGHCHAIR/STROLLER INSERT	Jun 22, 1994	Substantially Equivalent	Theradapt Products, Inc.
K930520	THERADAPT(R) ADJUSTABLE CLASSROOM CHAIR	Mar 24, 1993	Substantially Equivalent	Theradapt Products, Inc.
K923753	ABLE GENERATION THERAPY TILT BENCH	Jan 29, 1993	Substantially Equivalent	The Able Generation, Inc.
K923752	ABLE GENERATION PLAY CHAIR	Jan 29, 1993	Substantially Equivalent	The Able Generation, Inc.
K923750	ABLE GENERATION BOOSTER CHAIR	Jan 29, 1993	Substantially Equivalent	The Able Generation, Inc.
K923095	KAYE MODEL KIAO PELVIC/THIGH STABILIZER	Jul 21, 1992	Substantially Equivalent	Kaye Products, Inc.
K922061	CHAIR, ADJUSTABLE, MECHANICAL	May 26, 1992	Substantially Equivalent	Kaye Products, Inc.
K921272	ACTIVITY CHAIR	Apr 07, 1992	Substantially Equivalent	Rifton Equipment For the Handicapped
K904069	BRODA NURSING CARE CHAIR	Sep 17, 1990	Substantially Equivalent	Broda Ent., Inc.
K902951	SHOWER-A-WAY	Jul 25, 1990	Substantially Equivalent	Tri-S-Sales and Mfg.
K902600	THE COMPANION NON-ELECTRIC LIFT CHAIR	Jun 21, 1990	Substantially Equivalent	Innovative Medical Engineering, Inc.
K896814	TOI-LIFT	Feb 20, 1990	Substantially Equivalent	Mill-Tech Ent., Inc.
K894767	CORNER SEAT	Jan 17, 1990	Substantially Equivalent	Canadian Posture and Seating Centre, Inc.
K882090	HIP SAVER	May 26, 1988	Substantially Equivalent	Pride Health Care, Inc.
K874060	CONVERTA-LITTER	Dec 10, 1987	Substantially Equivalent	Camtec
K862957	MERIVAARA GERIATRIC CHAIR MODEL 455	Aug 21, 1986	Substantially Equivalent	Global Medical Prods, Inc.
K862885	CAR SEAT	Aug 14, 1986	Substantially Equivalent	Mednet, Inc.
K862883	ORTHOPEDIC SEATS	Aug 14, 1986	Substantially Equivalent	Mednet, Inc.
K841691	SPLIT SEAT POSITIONING CHAIR	May 09, 1984	Substantially Equivalent	Maddak, Inc.
K832511	RECLINING WHEELS	Aug 31, 1983	Substantially Equivalent	Reclining Wheels
K823277	THE PROGRESSIVE CHAIR	Dec 13, 1982	Substantially Equivalent	Progressive Productions , Ltd.
K821651	E-Z UP ARTHERAPEDIC CHAIR	Jun 24, 1982	Substantially Equivalent	Medical Device Consultants, Inc.
K812399	CHAIR, ADJUSTABLE, MECHANICAL	Sep 14, 1981	Substantially Equivalent	Kaye Products, Inc.
K812347	RAISED CHAIR W/FOOT PLATFORM	Sep 11, 1981	Substantially Equivalent	Fred Sammons, Inc.
K811484	SEATING STOOLS	Jun 16, 1981	Substantially Equivalent	Fred Sammons, Inc.