Data / Medical devices / United States / Ampcare, LLC
Ampcare, LLC: FDA-registered device maker in Fort Worth, TX, United States, 2 510(k) clearances
Ampcare, LLC is registered with the FDA (registration 3008273892) in Fort Worth, TX, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 31, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008273892
- Address
- 1120 South Fwy Suite 111, Fort Worth, TX, United States, 76104
- Owner or operator
- Ampcare (10042962)
- Roles
- Manufacturer
- First device listed
- January 15, 2013
- Registered through
- 2026
- Brand names listed
- AMPCARE E Series Electrodes, AMPCARE ES; AMPCARE ESP Therapy System, AMPCARE Restorative Posture Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Cervical-Thoracic, Rigid | IQF | 1 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 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 |
|---|---|---|---|---|---|---|
| October 31, 2013 | K131222 | AMPCARE ESP THERAPY SYSTEM | IPF | Substantially Equivalent | Ampcare, LLC | accessdata.fda.gov |
| October 15, 2012 | K121483 | REUSABLE CUTANEOUS ELECTRODE | GXY | Substantially Equivalent | Ampcare, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Cervical-Thoracic, Rigid
- All makers of Stimulator, Muscle, Powered
- All makers of Electrode, Cutaneous
Updated October 31, 2013. 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.