FDA product code IPG: Shoe, Cast
IPG is the FDA product code for shoe, cast. 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 IPG, from 6 different applicants. The average 510(k) review took 19 days (median 16).
Classification
| Field | Value |
|---|---|
| Device name | Shoe, Cast |
| 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 IPG clearance
Top IPG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ness-Neuromuscular Electrical Stimulation Systems | 1 | 2003-02-05 |
| Togard, Inc. | 1 | 1979-04-04 |
| Cutler Biomedical | 1 | 1978-08-14 |
| Ballert Orthopedic Corp. | 1 | 1978-04-18 |
| Richard'S Medical Equip., Inc. | 1 | 1976-10-06 |
1 more applicants have IPG clearances. See the full list in Caduvo.
Most recent IPG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K024279 | Ness-Neuromuscular Electrical Stimulation Systems | NESS CHILDREN SYSTEM | 2003-02-05 | 44 |
| K790652 | Togard, Inc. | TOGUARD | 1979-04-04 | 0 |
| K781363 | Cutler Biomedical | CAST SHOE | 1978-08-14 | 7 |
| K780617 | Ballert Orthopedic Corp. | EQUALIZER | 1978-04-18 | 5 |
| K760575 | Richard'S Medical Equip., Inc. | ROCKER-SOLE CAST SANDAL | 1976-10-06 | 33 |
Recalls for IPG devices
openFDA lists no recalls for product code IPG.
Frequently asked questions
What is FDA product code IPG?
IPG is the FDA product code for shoe, cast. It is a Class I device, regulated under 21 CFR 890.3025 and reviewed by the Physical Medicine panel.
What device class is IPG?
Class I, regulation 21 CFR 890.3025. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IPG?
Across 6 cleared submissions the average was 19 days from receipt to decision (median 16).
Which companies have the most IPG clearances?
Ness-Neuromuscular Electrical Stimulation Systems (1); Togard, Inc. (1); Cutler Biomedical (1); Ballert Orthopedic Corp. (1); Richard'S Medical Equip., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IPG
- Run a recall and safety report across every IPG manufacturer
- Watch product code IPG 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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