Data / Medical devices / United Kingdom / Firstkind Ltd
Firstkind Ltd: FDA-registered device maker in High Wycombe Buckinghamshire, United Kingdom, 4 510(k) clearances
Firstkind Ltd is registered with the FDA (registration 3011197543) in High Wycombe Buckinghamshire, United Kingdom. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 4, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011197543
- Address
- Suite 3, St Johns Court Easton Street, High Wycombe Buckinghamshire, United Kingdom, HP11 1JX
- Owner or operator
- Firstkind Ltd (10047447)
- Roles
- Specification developer
- First device listed
- May 30, 2018
- Registered through
- 2026
- Brand names listed
- A-2, firefly K-1, firefly T-2, geko K-1, geko T-2, geko T-3, geko W-3
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Joint, Knee, External Brace | ITQ | 1 | Specification developer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Specification developer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | 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 |
|---|---|---|---|---|---|---|
| March 4, 2022 | K220327 | geko W-3 | IPF | Substantially Equivalent | Firstkind Limited | accessdata.fda.gov |
| May 28, 2020 | K201131 | firefly T-2 | NGX | Substantially Equivalent | Firstkind Limited | accessdata.fda.gov |
| September 18, 2019 | K191113 | geko T-2 and geko T-3 Neuromuscular Stimulators | IPF | Substantially Equivalent | Firstkind Limited | accessdata.fda.gov |
| May 23, 2018 | K181059 | geko T-3 Neuromuscular Stimulator | IPF | Substantially Equivalent | Firstkind Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Tape And Bandage, Adhesive
- All makers of Joint, Knee, External Brace
Updated March 4, 2022. 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.