Product code ILD
- Device name
- Adaptor, Dressing
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.5050
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K831539 | ECONOMY PLASTIC SOCK-BK2084-AID | Fred Sammons, Inc. | 1983-06-08 |
| K823603 | FORMED PLASTIC PANTY HOSE AID | Fred Sammons, Inc. | 1982-12-28 |
| K823604 | ROD W/HOOK TO PULL CLOTHES ON | Fred Sammons, Inc. | 1982-12-28 |
| K823627 | LEATHER I VELCRO SHOE FASTENER REPAIR | Fred Sammons, Inc. | 1982-12-28 |
| K823628 | LEATHER & VELCRO SHOE FASTENER | Fred Sammons, Inc. | 1982-12-28 |
| K823602 | REGULAR SHOE HORN W/CYLINDRICAL HANDLE | Fred Sammons, Inc. | 1982-12-22 |
| K821856 | BK-2082 FOLDING STOCKING AID | Fred Sammons, Inc. | 1982-07-02 |
| K821858 | NOTIE STRETCH-LACE-VARIOUS MODELS | Fred Sammons, Inc. | 1982-07-02 |
| K821859 | ORTHOLACE 4,5.6 EYELET | Fred Sammons, Inc. | 1982-07-02 |
| K813634 | ONE HANDED SHOE FASTENER | Fred Sammons, Inc. | 1982-01-19 |
| K811492 | DRESSING ADAPTORS | Fred Sammons, Inc. | 1981-06-12 |
| K810453 | DRESSING ADAPTORS | Fred Sammons, Inc. | 1981-03-04 |
| K790171 | BK-2084 PLASTIC SOCK AND STOCKING AID | Fred Sammons, Inc. | 1979-02-08 |
| K760287 | BUTTON AID W/POCKET CLIP, BK-2011 | Fred Sammons, Inc. | 1976-09-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00818323025279 | Vive | VIVE HEALTH LLC | 2026-05-11 |
| 00818323022797 | Vive | VIVE HEALTH LLC | 2026-05-11 |
| 00023601042248 | Carex | Drive Devilbiss Healthcare | 2024-01-08 |
| 00023601042255 | Carex | Drive Devilbiss Healthcare | 2023-09-29 |
| 20653160256363 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-02 |
| 20653160256356 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-02 |
| 00653160290196 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-02 |
| 00822383989952 | Drive | Drive Devilbiss Healthcare | 2019-06-21 |
| 00822383546636 | DRIVEMEDICAL | Drive Devilbiss Healthcare | 2019-06-21 |
| 00822383546629 | DRIVEMEDICAL | Drive Devilbiss Healthcare | 2019-06-21 |
| 00822383546612 | DRIVEMEDICAL | Drive Devilbiss Healthcare | 2019-06-21 |
| 00779709030686 | DRIVEMEDICAL | Drive Devilbiss Healthcare | 2019-06-21 |
| 00779709020434 | DRIVEMEDICAL | Drive Devilbiss Healthcare | 2019-06-21 |
| 00779709020328 | DRIVEMEDICAL | Drive Devilbiss Healthcare | 2019-06-21 |
| 50050428442086 | DRIVEMEDICAL | Drive Devilbiss Healthcare | 2019-06-21 |
| 00779709020304 | DRIVEMEDICAL | Drive Devilbiss Healthcare | 2019-06-21 |
| 00779709020465 | Drive | Drive Devilbiss Healthcare | 2017-07-10 |
| 00779709020441 | Drive | Drive Devilbiss Healthcare | 2017-07-10 |
| 00779709095067 | Drive | Drive Devilbiss Healthcare | 2017-07-10 |
| 00779709020250 | Drive | Drive Devilbiss Healthcare | 2017-07-10 |
| 00779709020120 | Drive | Drive Devilbiss Healthcare | 2017-07-10 |
| 00779709020106 | Drive | Drive Devilbiss Healthcare | 2017-07-10 |
| 00779709010206 | DRIVEMEDICAL | Drive Devilbiss Healthcare | 2017-07-10 |
| 00179709020524 | Drive | Drive Devilbiss Healthcare | 2017-07-10 |
| 00822383546650 | Drive | Drive Devilbiss Healthcare | 2017-07-10 |
| 00822383546667 | Drive | Drive Devilbiss Healthcare | 2017-07-10 |
| 00822383546674 | Drive | Drive Devilbiss Healthcare | 2017-07-10 |
| 00822383546681 | Drive | Drive Devilbiss Healthcare | 2017-07-10 |
| 00822383546698 | Drive | Drive Devilbiss Healthcare | 2017-07-10 |
| 00779709020410 | Drive | Drive Devilbiss Healthcare | 2017-07-10 |