Data / Medical devices / Perineometer / United States
FDA-registered makers of Perineometer in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Perineometer (product code HIR). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Perineometer
- Product code
- HIR
- Country
- United States
Makers of Perineometer in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Advanced Tactile Imaging, Inc. | Trenton, NJ, United States | Manufacturer | 2 | February 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Pelvital Usa, Inc. | Eagan, MN, United States | Complaint file establishment, Specification developer | 2 | August 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Personal Medical Corp. | Bothell, WA, United States | Complaint file establishment, Specification developer | 2 | November 29, 2000 | 0 | 0 | 0 | api.fda.gov |
| The Prometheus Group | Dover, NH, United States | Manufacturer | 2 | December 22, 1997 | 0 | 0 | 0 | api.fda.gov |
| Axena Health, Inc. | Auburndale, MA, United States | Complaint file establishment, Specification developer | 1 | June 30, 2022 | 0 | 0 | 0 | api.fda.gov |
| Plus Ev Holdings Inc | North Kansas City, MO, United States | Complaint file establishment, Specification developer | 1 | August 24, 2020 | 0 | 0 | 0 | api.fda.gov |
| Incontrol Medical, LLC | Pewaukee, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laborie Medical Technologies Corp. | Portsmouth, NH, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med-Linket Corp | Alhambra, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nextern | Maple Grove, MN, United States | Contract manufacturer | 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.