Firstkind Ltd
High Wycombe Buckinghamshire, GB
FIRSTKIND LTD appears in FDA device records in High Wycombe Buckinghamshire, GB. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Firstkind Ltd between 2014 and 2022. The busiest year on record is 2014, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220327 | geko W-3 | IPF | Substantially Equivalent | |
| K212762 | geko W-2 | IPF | Substantially Equivalent | |
| K201131 | firefly T-2 | NGX | Substantially Equivalent | |
| K193045 | geko™ W-2 | IPF | Substantially Equivalent | |
| K191113 | geko T-2 and geko T-3 Neuromuscular Stimulators | IPF | Substantially Equivalent | |
| K181059 | geko T-3 Neuromuscular Stimulator | IPF | Substantially Equivalent | |
| K180082 | geko T-2 and geko Plus R-2 | IPF | Substantially Equivalent | |
| K163125 | geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators | IPF | Substantially Equivalent | |
| K160299 | geko(TM) Plus R-2 Neuromuscular Stimulator | IPF | Substantially Equivalent | |
| K152677 | geko T-2 Neuromuscular Stimulator | IPF | Substantially Equivalent | |
| K133638 | GEKO | IPF | Substantially Equivalent | |
| K134001 | FIREFLY | NGX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011197543 | 3011197543 | FIRSTKIND LTD | Suite 3, St Johns Court, High Wycombe Buckinghamshire HP11 1JX GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain