Product Code: ILS FDA class 1 21 CFR 890.5050

Adaptor, Hygiene

Physical Medicine

A Hygiene Adaptor is an assistive device used in Physical Medicine and occupational therapy to enable patients with limited hand function, upper limb disability, or reduced range of motion to independently perform personal hygiene tasks such as bathing, grooming, and toileting. 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 ILS, 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

301

Registration Numbers

301

Unique Applicants

Years Active

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Basic Information

Product Code: ILS
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 31 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K852049	MEDICAL TOILET SEAT	Jun 24, 1985	Substantially Equivalent	Pedro Aleman
K842651	COMMODE CHAIR 98200	Aug 07, 1984	Substantially Equivalent	Guardian Products Co., Inc.
K831547	RAISED TOILET SEATS & NAIL CLIPPERS	Jun 08, 1983	Substantially Equivalent	Fred Sammons, Inc.
K830853	LAVATORY SEAT HEIGHTENER	Jun 08, 1983	Substantially Equivalent	Lic-Orthion
K830425	TOILET SEAT RAISED	May 09, 1983	Substantially Equivalent	Maddak, Inc.
K830852	SHOWER STOOL W/HANDLES	Apr 05, 1983	Substantially Equivalent	Lic-Orthion
K823641	BATHING CHAIR FOR CHILD	Jan 21, 1983	Substantially Equivalent	Fred Sammons, Inc.
K823626	DISPOSABLE TOOTH BRUSH	Dec 30, 1982	Substantially Equivalent	Fred Sammons, Inc.
K823606	PLASTIC BREAK RESISTANT MIRROR	Dec 28, 1982	Substantially Equivalent	Fred Sammons, Inc.
K823156	COLLAPSABLE LAVATORY HEIGHTENER	Nov 05, 1982	Substantially Equivalent	Orthion Corp.
K823155	LAVATORY SEAT HEIGHTENER	Nov 05, 1982	Substantially Equivalent	Orthion Corp.
K821860	BK-6477 THE DERBY RAISED TOILET SEAT	Jul 02, 1982	Substantially Equivalent	Fred Sammons, Inc.
K821638	HYGIENE ADAPTORS	Jun 11, 1982	Substantially Equivalent	Fred Sammons, Inc.
K821009	BATHTUB GRAB BAR	Apr 21, 1982	Substantially Equivalent	Guardian Products Co., Inc.
K813635	CHILDS TOILET TRAINER HYGIENE AIDS	Jan 19, 1982	Substantially Equivalent	Fred Sammons, Inc.
K812483	SECURA BATH SEAT	Sep 14, 1981	Substantially Equivalent	Maddak, Inc.
K812352	HYGIENE ADAPTORS	Sep 14, 1981	Substantially Equivalent	Fred Sammons, Inc.
K811301	TUBMATE	May 27, 1981	Substantially Equivalent	American Stair-Glide Corp.
K810456	HYGIENE ADAPTORS	Mar 04, 1981	Substantially Equivalent	Fred Sammons, Inc.
K802511	GARELICK COMMODE	Nov 12, 1980	Substantially Equivalent	Garelick Mfg. Co.
K791423	TOILET TRAINER FOR HANDICAPPED CHILD	Aug 10, 1979	Substantially Equivalent	Kaye Products, Inc.
K790531	ANUS STIMULATOR	Apr 26, 1979	Substantially Equivalent	Maddak, Inc.
K790175	SEMI-RECLINING BATH CHARI & BELT	Feb 22, 1979	Substantially Equivalent	Fred Sammons, Inc.
K790178	WATER POWERED BATH CHAIR LIFT	Feb 08, 1979	Substantially Equivalent	Fred Sammons, Inc.
K781614	MOTOR RISER TOLIT LIFT	Oct 03, 1978	Substantially Equivalent	Motor Riser Chairs , Ltd.
K781205	TOILET AID	Jul 31, 1978	Substantially Equivalent	Fred Sammons, Inc.
K761130	BATHTUB RAILS	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.
K761129	CONTOURED RAISED TOILET SEAT	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.
K761127	LONG HANDLED BATH BRUSH	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.
K761126	EXTRA LARGE LONG HANDLED SPONGE	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.
K761125	LONG HANDLED SPONGE	Dec 02, 1976	Substantially Equivalent	Fred Sammons, Inc.