Data / Medical devices / United Kingdom / Odstock Medical Ltd
Odstock Medical Ltd: FDA-registered device maker in SALISBURY Wiltshire, United Kingdom, 1 510(k) clearance
Odstock Medical Ltd is registered with the FDA (registration 3005344585) in SALISBURY Wiltshire, United Kingdom. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 31, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005344585
- Address
- SALISBURY DISTRICT HOSPITAL National Clinical FES Centre, SALISBURY Wiltshire, United Kingdom, SP2 8BJ
- Owner or operator
- ODSTOCK MEDICAL LTD (9076759)
- Roles
- Manufacturer
- First device listed
- June 29, 2018
- Registered through
- 2026
- Brand names listed
- ODFS Pace XL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Neuromuscular, External Functional | GZI | 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 |
|---|---|---|---|---|---|---|
| January 31, 2018 | K171396 | ODFS Pace XL | GZI | Substantially Equivalent | Odstock Medical, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Neuromuscular, External Functional
- All makers of Stimulator, Muscle, Powered
Updated January 31, 2018. 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.