ILS · Adaptor, Hygiene
Physical Medicine · 21 CFR 890.5050 · Class 1
Overview
| Product Code | ILS |
|---|---|
| Device Name | Adaptor, Hygiene |
| Regulation | 21 CFR 890.5050 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. If the device is not labeled or otherwise represented as sterile, the device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 31)
Showing 20 most recent of 31 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K852049 | MEDICAL TOILET SEAT | Pedro Aleman | Jun 24, 1985 | SESE |
| K842651 | COMMODE CHAIR 98200 | Guardian Products Co., Inc. | Aug 7, 1984 | SESE |
| K831547 | RAISED TOILET SEATS & NAIL CLIPPERS | Fred Sammons, Inc. | Jun 8, 1983 | SESE |
| K830853 | LAVATORY SEAT HEIGHTENER | Lic-Orthion | Jun 8, 1983 | SESE |
| K830425 | TOILET SEAT RAISED | Maddak, Inc. | May 9, 1983 | SESE |
| K830852 | SHOWER STOOL W/HANDLES | Lic-Orthion | Apr 5, 1983 | SESE |
| K823641 | BATHING CHAIR FOR CHILD | Fred Sammons, Inc. | Jan 21, 1983 | SESE |
| K823626 | DISPOSABLE TOOTH BRUSH | Fred Sammons, Inc. | Dec 30, 1982 | SESE |
| K823606 | PLASTIC BREAK RESISTANT MIRROR | Fred Sammons, Inc. | Dec 28, 1982 | SESE |
| K823156 | COLLAPSABLE LAVATORY HEIGHTENER | Orthion Corp. | Nov 5, 1982 | SESE |
| K823155 | LAVATORY SEAT HEIGHTENER | Orthion Corp. | Nov 5, 1982 | SESE |
| K821860 | BK-6477 THE DERBY RAISED TOILET SEAT | Fred Sammons, Inc. | Jul 2, 1982 | SESE |
| K821638 | HYGIENE ADAPTORS | Fred Sammons, Inc. | Jun 11, 1982 | SESE |
| K821009 | BATHTUB GRAB BAR | Guardian Products Co., Inc. | Apr 21, 1982 | SESE |
| K813635 | CHILDS TOILET TRAINER HYGIENE AIDS | Fred Sammons, Inc. | Jan 19, 1982 | SESE |
| K812483 | SECURA BATH SEAT | Maddak, Inc. | Sep 14, 1981 | SESE |
| K812352 | HYGIENE ADAPTORS | Fred Sammons, Inc. | Sep 14, 1981 | SESE |
| K811301 | TUBMATE | American Stair-Glide Corp. | May 27, 1981 | SESE |
| K810456 | HYGIENE ADAPTORS | Fred Sammons, Inc. | Mar 4, 1981 | SESE |
| K802511 | GARELICK COMMODE | Garelick Mfg. Co. | Nov 12, 1980 | SESE |
Top Applicants
- Fred Sammons, Inc. — 17 clearances
- Maddak, Inc. — 3 clearances
- Guardian Products Co., Inc. — 2 clearances
- Lic-Orthion — 2 clearances
- Orthion Corp. — 2 clearances
