Data / Medical devices / Monitor, Orthotic/Prosthetic
Monitor, Orthotic/Prosthetic (NHF): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Monitor, Orthotic/Prosthetic (product code NHF, Class 1, 21 CFR 890.3025). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NHF
- Device class
- 1
- Regulation
- 890.3025
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Poland | 1 |
| Japan | 1 |
| Canada | 1 |
Makers of Monitor, Orthotic/Prosthetic
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aether Biomedical SP. Z O.O. | Poznan Wielkopolskie, Poland | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Brace International, Incorporated | Stoughton, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Click Medical | Steamboat Springs, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfort Products, Inc. | Croydon, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Imasen Engineering Corporation | Kakamigahara Gifu, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovative Neurotronics Inc. | Reno, NV, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Levy & Rappel | Saddle Brook, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Momentum Health Inc. | Montreal Quebec, Canada | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Opos1 | Waterloo, IA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spinal Technology, LLC | West Yarmouth, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spinal Systems, LLC | Louisville, KY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.