FDA product code PMW: Strabismus Detection Device
PMW is the FDA product code for strabismus detection device. It is a Class II device, regulated under 21 CFR 886.1342 and reviewed by the Ophthalmic panel. Devices under PMW reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it. FDA has posted 1 recall for PMW devices, 1 initiated in the last five years.
Definition
For the automated detection of misalignment of the visual axes for prescription use only.
Classification
| Field | Value |
|---|---|
| Device name | Strabismus Detection Device |
| Device class | Class II |
| Regulation | 21 CFR 886.1342 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
Recalls for PMW devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-10-03.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code PMW?
PMW is the FDA product code for strabismus detection device. It is a Class II device, regulated under 21 CFR 886.1342 and reviewed by the Ophthalmic panel.
What device class is PMW?
Class II, regulation 21 CFR 886.1342. Typical premarket route: 510(k).
Have PMW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-10-03.
Next steps
- Run an FDA pathway report with predicate devices for product code PMW
- Run a recall and safety report across every PMW manufacturer
- Watch product code PMW 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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