Data / Medical devices / France / Physio-Assist
Physio-Assist: FDA-registered device maker in Aix-en-Provence Provence-Alpes-Cote d'Azur, France, 1 510(k) clearance
Physio-Assist is registered with the FDA (registration 3019585099) in Aix-en-Provence Provence-Alpes-Cote d'Azur, France. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019585099
- Address
- 31 parc du Golf CS 90519, Aix-en-Provence Provence-Alpes-Cote d'Azur, France, 13593
- Owner or operator
- Inogen (10092925)
- Roles
- Manufacturer
- First device listed
- March 6, 2025
- Registered through
- 2026
- Brand names listed
- PHYSIO-ASSIST
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intra-Pulmonary Percussive Vibration (Ipv) Devices | SDT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 23, 2024 | K241091 | SIMEOX 200 Airway Clearance Device | SDT | Substantially Equivalent | Inogen, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 23, 2024. 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.