Product code IPM
- Device name
- Cover, Limb
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3025
- 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 |
|---|---|---|---|
| K872488 | ELASTO-GEL CAST & SPLINT PADS | Southwest Technologies, Inc. | 1987-09-21 |
| K823399 | COVER LIMB | Orthopedic Systems, Inc. | 1982-11-29 |
| K801627 | COVER, LIMB | The Owenby Co. | 1980-07-28 |
| K780905 | LIMB COVER | Hydro-Med Products, Inc. | 1978-08-14 |
| K770223 | HEAVY FOAM HEEL & ELBOW PROTECTORS | Robert R. Moore | 1977-02-23 |
| K761114 | FOAM SLIPPERS | Fred Sammons, Inc. | 1976-12-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10809160489888 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2025-08-01 |
| 10809160489468 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2025-07-31 |
| 00194711300969 | One | Willowwood Global LLC | 2025-03-21 |
| 00194711300952 | One | Willowwood Global LLC | 2025-03-21 |
| 00194711300945 | One | Willowwood Global LLC | 2025-03-21 |
| 00194711300938 | One | Willowwood Global LLC | 2025-03-21 |
| 00194711300921 | One | Willowwood Global LLC | 2025-03-21 |
| 00194711300914 | One | Willowwood Global LLC | 2025-03-21 |
| 00194711300891 | One | Willowwood Global LLC | 2025-03-21 |
| 00194711300846 | One | Willowwood Global LLC | 2025-03-21 |
| M220P0725233 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2022-10-11 |
| M220P0725033 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2022-10-10 |
| M220P0725023 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2022-10-10 |
| M220P0725043 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2022-10-10 |
| M220P0725223 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2022-10-10 |
| M220P0725243 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2022-10-10 |
| 20680651536055 | Halyard | O&M HALYARD, INC. | 2020-11-18 |
| 20680651536000 | Halyard | O&M HALYARD, INC. | 2020-11-18 |
| 20612479123575 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2018-09-12 |
| 20612479123582 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2018-09-12 |
| 20612479123568 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2018-09-12 |
| 10887488919942 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2018-03-26 |
| 10886982199461 | NA | Synthes GmbH | 2016-12-31 |
| 10809160025420 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 10809160016725 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 10809160016718 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 10809160016701 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 10809160016695 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 10809160017579 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 10809160017586 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |