ILD · Adaptor, Dressing
Physical Medicine · 21 CFR 890.5050 · Class 1
Overview
| Product Code | ILD |
|---|---|
| Device Name | Adaptor, Dressing |
| 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 (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K831539 | ECONOMY PLASTIC SOCK-BK2084-AID | Fred Sammons, Inc. | Jun 8, 1983 | SESE |
| K823628 | LEATHER & VELCRO SHOE FASTENER | Fred Sammons, Inc. | Dec 28, 1982 | SESE |
| K823627 | LEATHER I VELCRO SHOE FASTENER REPAIR | Fred Sammons, Inc. | Dec 28, 1982 | SESE |
| K823604 | ROD W/HOOK TO PULL CLOTHES ON | Fred Sammons, Inc. | Dec 28, 1982 | SESE |
| K823603 | FORMED PLASTIC PANTY HOSE AID | Fred Sammons, Inc. | Dec 28, 1982 | SESE |
| K823602 | REGULAR SHOE HORN W/CYLINDRICAL HANDLE | Fred Sammons, Inc. | Dec 22, 1982 | SESE |
| K821859 | ORTHOLACE 4,5.6 EYELET | Fred Sammons, Inc. | Jul 2, 1982 | SESE |
| K821858 | NOTIE STRETCH-LACE-VARIOUS MODELS | Fred Sammons, Inc. | Jul 2, 1982 | SESE |
| K821856 | BK-2082 FOLDING STOCKING AID | Fred Sammons, Inc. | Jul 2, 1982 | SESE |
| K813634 | ONE HANDED SHOE FASTENER | Fred Sammons, Inc. | Jan 19, 1982 | SESE |
| K811492 | DRESSING ADAPTORS | Fred Sammons, Inc. | Jun 12, 1981 | SESE |
| K810453 | DRESSING ADAPTORS | Fred Sammons, Inc. | Mar 4, 1981 | SESE |
| K790171 | BK-2084 PLASTIC SOCK AND STOCKING AID | Fred Sammons, Inc. | Feb 8, 1979 | SESE |
| K760287 | BUTTON AID W/POCKET CLIP, BK-2011 | Fred Sammons, Inc. | Sep 8, 1976 | SESE |
Top Applicants
- Fred Sammons, Inc. — 14 clearances
