Product Code: KNN FDA class 1 21 CFR 890.3920

Components, Wheelchair

Physical Medicine

Wheelchair Components are structural and functional parts used to assemble, repair, or modify manual or powered wheelchairs, including frames, wheels, footrests, armrests, and related structural elements that support mobility for individuals with physical disabilities. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket clearance required. The product code is KNN and it is regulated under 21 CFR 890.3920 in the Physical Medicine specialty.

View on FDA

510(k)s

FEI Numbers

137

Registration Numbers

137

Unique Applicants

Years Active

Research product code KNN in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: KNN
Device Class: FDA class 1
Regulation Number: 890.3920
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 64 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K211919	KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat	Mar 04, 2022	Substantially Equivalent	Kinetic Innovative Seating System, LLC
K942311	DYNASTY U1-33 AGM	Nov 07, 1994	Substantially Equivalent	Foley & Lardner
K942310	DYNASTY GC 12550 (GELL/CELL)	Nov 07, 1994	Substantially Equivalent	Foley & Lardner
K942309	DYNASTY U1-31 (GELL/CELL)	Nov 07, 1994	Substantially Equivalent	Foley & Lardner
K942308	DYNASTY GC 12400 (GELL/CELL)	Nov 07, 1994	Substantially Equivalent	Foley & Lardner
K942312	ALDEN LINEAGE WHEELCHAIR CUSHION	May 26, 1994	Substantially Equivalent	Lewis W. Ward
K942260	ALDEN WHEELCHAIR CUSHION	May 26, 1994	Substantially Equivalent	Ward and Assoc.
K933051	ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION	Oct 12, 1993	Substantially Equivalent	General Components Intl., Inc.
K925980	PM	Mar 24, 1993	Substantially Equivalent	Pathfinder Intl. Corp.
K923942	RHOMBO MEDICAL RHOMBO-FILL	Mar 24, 1993	Substantially Equivalent	International Medical Products, Inc.
K923364	TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST	Mar 22, 1993	Substantially Equivalent	Labac Systems, Inc.
K925336	VALU-PLUS PAD	Feb 12, 1993	Substantially Equivalent	Valmed, Inc.
K923366	TILT SEATING SYSTEM	Feb 12, 1993	Substantially Equivalent	Labac Systems, Inc.
K923186	NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC	Sep 09, 1992	Substantially Equivalent	Roho, Inc.
K921369	BIOMEDICAL HORIZONS MODEL 1001	May 11, 1992	Substantially Equivalent	Biomedical Horizons, Inc.
K921027	MANUAL CHAIR BASE	Mar 20, 1992	Substantially Equivalent	Labac Systems, Inc.
K915629	CUSHION, WHELCHAR AND FLOTATION	Jan 09, 1992	Substantially Equivalent	Invacare Corp.
K915368	SERENA WHEELCHAIR CUSHIONS	Dec 20, 1991	Substantially Equivalent	A & C Medical Supply
K913553	PIN DOT GROWTH/DIAL LINKS	Sep 05, 1991	Substantially Equivalent	Pin Dot Products, Inc.
K913550	PIN DOT TRUNION MOUNTS	Sep 05, 1991	Substantially Equivalent	Pin Dot Products, Inc.
K913549	PIN DOT MOUNTING BRACKETS	Sep 05, 1991	Substantially Equivalent	Pin Dot Products, Inc.
K913548	PIN DOT ALUMINUM PAN	Sep 05, 1991	Substantially Equivalent	Pin Dot Products, Inc.
K913546	IMPALA CASTERS	Sep 05, 1991	Substantially Equivalent	Pin Dot Products, Inc.
K913545	PIN DOT FLIP-DOWN ABDUCTOR	Sep 05, 1991	Substantially Equivalent	Pin Dot Products, Inc.
K913511	IMPALA AXLES	Sep 05, 1991	Substantially Equivalent	Pin Dot Products, Inc.
K913509	IMPALA WHEELS	Sep 05, 1991	Substantially Equivalent	Pin Dot Products, Inc.
K913507	ARMREST	Sep 05, 1991	Substantially Equivalent	Pin Dot Products, Inc.
K913552	PIN DOT FOOTREST PRODUCTS	Aug 29, 1991	Substantially Equivalent	Pin Dot Products, Inc.
K905013	T.C.S. TOTAL CONTACT SEAT	Dec 19, 1990	Substantially Equivalent	Fundamental Products Co.
K904913	HANDI-TRAK WHEELCHAIR SNOW CHAINS	Nov 07, 1990	Substantially Equivalent	Handi-Trak, Inc.
K900839	THE CAROLINA ROCKER	Apr 18, 1990	Substantially Equivalent	Artec Environmental Monitoring Division
K894770	PERSONAL BACK WITH FIP KIT	Sep 11, 1989	Substantially Equivalent	Canadian Posture and Seating Centre, Inc.
K890178	WHEELCHAIR STUMP SUPPORT	Sep 11, 1989	Substantially Equivalent	Gerber Chair Mates, Inc.
K894960	E.Z. LOCK WHEELCHAIR RESTRAINT DEVICE	Sep 05, 1989	Substantially Equivalent	E.Z. Lock, Inc.
K885106	REMOVABLE BATTERY POWER SYSTEM	Dec 27, 1988	Substantially Equivalent	Rolcontrol Products, Co., Inc.
K885105	SLIDING ARM SUPPORT	Dec 27, 1988	Substantially Equivalent	Rolcontrol Products, Co., Inc.
K885104	LAYDOWN ARM SUPPORT MECHANISM	Dec 27, 1988	Substantially Equivalent	Rolcontrol Products, Co., Inc.
K884052	GILLUM'S WHEELCHAIR WIDTH REDUCING ATTACHMENT	Oct 26, 1988	Substantially Equivalent	Professional Service Unltd.
K883679	WHEELS-OFF QUICK RELEASE AXLE SYSTEM	Sep 13, 1988	Substantially Equivalent	Rolcontrol Products, Co., Inc.
K882253	STOUTE'S ASSIST-SEAT WHEELCHAIR COMPONENT	Jun 27, 1988	Substantially Equivalent	Stoute'S "Assist-Seat" Corp.
K882012	LIFESTYLE SOF. CARE GEL CHAIR CUSHION	May 23, 1988	Substantially Equivalent	Gaymar Industries, Inc.
K870698	VAN-TEC PROSTATE BIOPSY NEEDLE	Mar 25, 1987	Substantially Equivalent	Van-Tec, Inc.
K870299	REDMAN UPHOLSTERY SERIES FOR WHEELCHAIRS	Feb 10, 1987	Substantially Equivalent	Redman, Inc.
K863385	(ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE	Nov 04, 1986	Substantially Equivalent	Cook Urological, Inc.
K862887	UPHOLSTERED BUCKET SEAT	Aug 14, 1986	Substantially Equivalent	Mednet, Inc.
K861755	SHS CUSHION/WHEELCHAIR	May 23, 1986	Substantially Equivalent	Special Health Systems, Ltd.
K861754	KINESETHETIC SEATING SYSTEM/WHEELCHAIR	May 23, 1986	Substantially Equivalent	Special Health Systems, Ltd.
K861751	THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS	May 23, 1986	Substantially Equivalent	Special Health Systems, Ltd.
K854710	BOTTOMS-UP TM PELVIC SPINAL POSTURE-AID	Apr 16, 1986	Substantially Equivalent for Some Indications	Reloke Co.
K855181	COMFORTEX WHEELCHAIR CUSHION	Jan 13, 1986	Substantially Equivalent	Comfortex, Inc.
K840629	WHEELCHAIR ACCESSORIES	Feb 27, 1984	Substantially Equivalent	Poirier S.A.
K823638	ARM THROUGH FOR WHEELCHAIR BK 6454-01 &	Jan 21, 1983	Substantially Equivalent	Fred Sammons, Inc.
K823637	ARM THROUGH FOR WHEELCHAIR BK-6458-01	Jan 21, 1983	Substantially Equivalent	Fred Sammons, Inc.
K823877	BERKELEY HARNESS	Jan 14, 1983	Substantially Equivalent	Berkeley Electric Wheelchair Co.
K823876	BERKELEY FORK	Jan 14, 1983	Substantially Equivalent	Berkeley Electric Wheelchair Co.
K823875	CHAIN KIT	Jan 14, 1983	Substantially Equivalent	Berkeley Electric Wheelchair Co.
K823874	BERKELEY BRAKE	Jan 14, 1983	Substantially Equivalent	Berkeley Electric Wheelchair Co.
K823873	CHAIN SILENCER	Jan 14, 1983	Substantially Equivalent	Berkeley Electric Wheelchair Co.
K821488	ELECATH PORTAL VEIN/BILIARY DRAIN ASSM	May 28, 1982	Substantially Equivalent	Electro-Catheter Corp.
K820761	PALM BEACH SEATING SYSTEM	Apr 21, 1982	Substantially Equivalent	Pb Sales C/O Geller & Bozeman
K813636	BK-6470 ADJUSTABLE ELEVATING WHEELCHAIR	Jan 19, 1982	Substantially Equivalent	Fred Sammons, Inc.
K812348	DESK ARM WHEELCHAIR ARM EXTENSION	Sep 11, 1981	Substantially Equivalent	Fred Sammons, Inc.
K780192	LEGREST, ELEVATING	Feb 14, 1978	Substantially Equivalent	Orthopedic Equipment Co., Inc.
K771631	WHEELCHAIR SAFETY BELT	Sep 12, 1977	Substantially Equivalent	Medical Restraints, Inc.