FDA product code PMV: Orthosis, Limb, For Back Pain
PMV is the FDA product code for orthosis, limb, for back pain. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under PMV. The average 510(k) review took 269 days (median 269).
Definition
Intended to provide pressure to the soleus muscle for the purpose of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities.
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Limb, For Back Pain |
| Device class | Class I |
| Regulation | 21 CFR 890.3475 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Top PMV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Natures Pillows, Inc. | 1 | 2016-02-26 |
Most recent PMV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K151476 | Natures Pillows, Inc. | Beactive Brace | 2016-02-26 | 269 |
Recalls for PMV devices
openFDA lists no recalls for product code PMV.
Frequently asked questions
What is FDA product code PMV?
PMV is the FDA product code for orthosis, limb, for back pain. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel.
What device class is PMV?
Class I, regulation 21 CFR 890.3475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PMV?
Across 1 cleared submissions the average was 269 days from receipt to decision (median 269).
Which companies have the most PMV clearances?
Natures Pillows, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PMV
- Run a recall and safety report across every PMV manufacturer
- Watch product code PMV 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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