Cover, Limb
FDA product code IPM · Class I (low risk) · 21 CFR 890.3025 · Physical Medicine
6510(k) clearances
0PMA approvals
1recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K872488 | Elasto-Gel Cast & Splint PadsIPM · Traditional | Southwest Technologies, Inc. | 09/21/1987SN |
| K823399 | Cover LimbIPM · Traditional | Orthopedic Systems, Inc. | 11/29/1982SE |
| K801627 | Cover, LimbIPM · Traditional | The Owenby Co. | 07/28/1980SE |
| K780905 | Limb CoverIPM · Traditional | Hydro-Med Products, Inc. | 08/14/1978SE |
| K770223 | Heavy Foam Heel & Elbow ProtectorsIPM · Traditional | Robert R. Moore | 02/23/1977SE |
| K761114 | Foam SlippersIPM · Traditional | Fred Sammons, Inc. | 12/02/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1594-2021 Class II | Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha…the firm discovered that, starting on April 1, 2020, a 3/8 dowel pin was used in place of the 5/8 pin. Over… | WillowWood Global Llc | 04/20/2021Open, Classified |