FDA product code IPM: Cover, Limb
IPM is the FDA product code for cover, limb. It is a Class I device, regulated under 21 CFR 890.3025 and reviewed by the Physical Medicine panel. FDA has cleared 6 510(k) submissions under IPM, from 6 different applicants. The average 510(k) review took 38 days (median 18). FDA has posted 1 recall for IPM devices.
Classification
| Field | Value |
|---|---|
| Device name | Cover, Limb |
| Device class | Class I |
| Regulation | 21 CFR 890.3025 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IPM clearance
Top IPM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Southwest Technologies, Inc. | 1 | 1987-09-21 |
| Orthopedic Systems, Inc. | 1 | 1982-11-29 |
| The Owenby Co. | 1 | 1980-07-28 |
| Hydro-Med Products, Inc. | 1 | 1978-08-14 |
| Robert R. Moore | 1 | 1977-02-23 |
1 more applicants have IPM clearances. See the full list in Caduvo.
Most recent IPM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872488 | Southwest Technologies, Inc. | ELASTO-GEL CAST & SPLINT PADS | 1987-09-21 | 90 |
| K823399 | Orthopedic Systems, Inc. | COVER LIMB | 1982-11-29 | 17 |
| K801627 | The Owenby Co. | COVER, LIMB | 1980-07-28 | 13 |
| K780905 | Hydro-Med Products, Inc. | LIMB COVER | 1978-08-14 | 73 |
| K770223 | Robert R. Moore | HEAVY FOAM HEEL & ELBOW PROTECTORS | 1977-02-23 | 20 |
Recalls for IPM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-04-20.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code IPM?
IPM is the FDA product code for cover, limb. It is a Class I device, regulated under 21 CFR 890.3025 and reviewed by the Physical Medicine panel.
What device class is IPM?
Class I, regulation 21 CFR 890.3025. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IPM?
Across 6 cleared submissions the average was 38 days from receipt to decision (median 18).
Which companies have the most IPM clearances?
Southwest Technologies, Inc. (1); Orthopedic Systems, Inc. (1); The Owenby Co. (1); Hydro-Med Products, Inc. (1); Robert R. Moore (1).
Have IPM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-04-20.
Next steps
- Run an FDA pathway report with predicate devices for product code IPM
- Run a recall and safety report across every IPM manufacturer
- Watch product code IPM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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