Adaptor, Dressing
A Dressing Adaptor is an assistive device used in Physical Medicine and occupational therapy to help patients with limited range of motion, strength, or hand dexterity to independently dress and undress, supporting rehabilitation and independent living. 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 ILD, 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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Basic Information
- Product Code
- ILD
- Device Class
- FDA class 1
- Regulation Number
- 890.5050
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K831539 | ECONOMY PLASTIC SOCK-BK2084-AID | Jun 08, 1983 | Substantially Equivalent | Fred Sammons, Inc. |
| K823628 | LEATHER & VELCRO SHOE FASTENER | Dec 28, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K823627 | LEATHER I VELCRO SHOE FASTENER REPAIR | Dec 28, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K823604 | ROD W/HOOK TO PULL CLOTHES ON | Dec 28, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K823603 | FORMED PLASTIC PANTY HOSE AID | Dec 28, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K823602 | REGULAR SHOE HORN W/CYLINDRICAL HANDLE | Dec 22, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K821859 | ORTHOLACE 4,5.6 EYELET | Jul 02, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K821858 | NOTIE STRETCH-LACE-VARIOUS MODELS | Jul 02, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K821856 | BK-2082 FOLDING STOCKING AID | Jul 02, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K813634 | ONE HANDED SHOE FASTENER | Jan 19, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K811492 | DRESSING ADAPTORS | Jun 12, 1981 | Substantially Equivalent | Fred Sammons, Inc. |
| K810453 | DRESSING ADAPTORS | Mar 04, 1981 | Substantially Equivalent | Fred Sammons, Inc. |
| K790171 | BK-2084 PLASTIC SOCK AND STOCKING AID | Feb 08, 1979 | Substantially Equivalent | Fred Sammons, Inc. |
| K760287 | BUTTON AID W/POCKET CLIP, BK-2011 | Sep 08, 1976 | Substantially Equivalent | Fred Sammons, Inc. |
FEI Numbers
This FDA classification entry is associated with 58 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 58 registration numbers. Click on an entry to view related FDA registrations.