Product Code: IKX FDA class 1 21 CFR 890.5050

Aid, Transfer

Physical Medicine

A Transfer Aid is a device used in Physical Medicine and occupational therapy to assist caregivers and patients in safely moving individuals with limited mobility from one surface to another, such as from a bed to a wheelchair or a chair to a vehicle, reducing injury risk for both patient and caregiver. 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 IKX, regulated under 21 CFR 890.5050, 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

282

Registration Numbers

282

Unique Applicants

Years Active

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Basic Information

Product Code: IKX
Device Class: FDA class 1
Regulation Number: 890.5050
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 18 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K862895	TRICYCLES	Aug 13, 1986	Substantially Equivalent	Mednet, Inc.
K842650	WALL GRAB BARS 98130-98136	Aug 10, 1984	Substantially Equivalent	Guardian Products Co., Inc.
K831541	TUB TRANSFER BENCH BK6481	Jun 02, 1983	Substantially Equivalent	Fred Sammons, Inc.
K823640	BATH TUB SAFETY BAR	Jan 21, 1983	Substantially Equivalent	Fred Sammons, Inc.
K823639	BOARD TO TRANSFER PARALYZED PATIENT FROM	Jan 21, 1983	Substantially Equivalent	Fred Sammons, Inc.
K823634	CHAIR OR BED LEG EXTENDERS	Dec 28, 1982	Substantially Equivalent	Fred Sammons, Inc.
K823154	SHOWER STOOL W/HANDLES	Nov 05, 1982	Substantially Equivalent	Orthion Corp.
K823153	BATH TUB SEAT & BATH BOARD	Nov 05, 1982	Substantially Equivalent	Orthion Corp.
K821903	DISC-O-AID	Jul 20, 1982	Substantially Equivalent	M. Dahm International Aps
K821010	BATHTUB TRANSFER BENCH	Apr 21, 1982	Substantially Equivalent	Guardian Products Co., Inc.
K813629	BK-6111 HI-D TRANSFER BOARD	Jan 19, 1982	Substantially Equivalent	Fred Sammons, Inc.
K812475	TRANSFER BENCH	Sep 14, 1981	Substantially Equivalent	Maddak, Inc.
K810449	TRANSFER AIDS	Mar 04, 1981	Substantially Equivalent	Fred Sammons, Inc.
K810275	GRAB BARS	Feb 12, 1981	Substantially Equivalent	Maddak, Inc.
K792247	TAYLOR PATIENT TRANSFER BOARD	Nov 30, 1979	Substantially Equivalent	Taylor Medical Equipment
K781201	BOARD, TRANSFER, FENDER	Jul 31, 1978	Substantially Equivalent	Fred Sammons, Inc.
K780935	GRAB BAR	Jun 19, 1978	Substantially Equivalent	Orthopedic Equipment Co., Inc.
K772417	SLIDING BOARD	Jan 05, 1978	Substantially Equivalent	Fred Sammons, Inc.