Data / Medical devices / United Kingdom / Compedica Limited
Compedica Limited: FDA-registered device maker in Wyboston Bedford, United Kingdom, 1 510(k) clearance
Compedica Limited is registered with the FDA (registration 3012174974) in Wyboston Bedford, United Kingdom. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 16, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012174974
- Address
- The Knowledge Centre Wyboston Lakes, Great North Rd, Wyboston Bedford, United Kingdom, MK44 3BY
- Owner or operator
- Compedica Holdings Limited (10051096)
- Roles
- Specification developer
- First device listed
- February 3, 2016
- Registered through
- 2026
- Brand names listed
- OptiPulse Active Therapy System, PulseFlow Aresta Protective Insole, PulseFlow DF
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthosis, Corrective Shoe | KNP | 1 | Specification developer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Specification developer | 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 16, 2015 | K150806 | PulseFlowDF | JOW | Substantially Equivalent | Pulseflow Technologies | accessdata.fda.gov |
Compare with other makers
Updated December 16, 2015. 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.