FDA product code MNE: Orthosis, Moldable, Supportive, Skin Protective
MNE is the FDA product code for orthosis, moldable, supportive, skin protective. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel. FDA has cleared 2 510(k) submissions under MNE. The average 510(k) review took 182 days (median 182).
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Moldable, Supportive, Skin Protective |
| Device class | Class I |
| Regulation | 21 CFR 890.3475 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MNE clearance
Top MNE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Crown Delta Corp. | 2 | 1994-09-29 |
Most recent MNE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K940132 | Crown Delta Corp. | PODIATRIC MATERIAL | 1994-09-29 | 269 |
| K780391 | Crown Delta Corp. | PODIATRIC MATERIAL | 1978-06-14 | 96 |
Recalls for MNE devices
openFDA lists no recalls for product code MNE.
Frequently asked questions
What is FDA product code MNE?
MNE is the FDA product code for orthosis, moldable, supportive, skin protective. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel.
What device class is MNE?
Class I, regulation 21 CFR 890.3475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MNE?
Across 2 cleared submissions the average was 182 days from receipt to decision (median 182).
Which companies have the most MNE clearances?
Crown Delta Corp. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code MNE
- Run a recall and safety report across every MNE manufacturer
- Watch product code MNE 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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