FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
geko W-3
K Number: K220327
·
Decision Mar 4, 2022
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
11
Review Days
28
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Basic Information
- Device Name
- geko W-3
- K Number
- K220327
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Firstkind Limited
- Date Received
- February 4, 2022
- Decision Date
- March 4, 2022
- Product Code
- IPF
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Firstkind Limited
| K Number | Device Name | ||
|---|---|---|---|
| K212762 | geko W-2 | Nov 29, 2021 | Substantially Equivalent |
| K201131 | firefly T-2 | May 28, 2020 | Substantially Equivalent |
| K193045 | geko W-2 | Jan 18, 2020 | Substantially Equivalent |
| K191113 | geko T-2 and geko T-3 Neuromuscular Stimulators | Sep 18, 2019 | Substantially Equivalent |
| K181059 | geko T-3 Neuromuscular Stimulator | May 23, 2018 | Substantially Equivalent |
| K163125 | geko T-2 and geko Plus R-2 Neuromuscular Stimulators | Apr 10, 2017 | Substantially Equivalent |
| K160299 | geko(TM) Plus R-2 Neuromuscular Stimulator | Apr 8, 2016 | Substantially Equivalent |
| K152677 | geko T-2 Neuromuscular Stimulator | Oct 23, 2015 | Substantially Equivalent |
| K133638 | GEKO | Aug 21, 2014 | Substantially Equivalent |
| K134001 | FIREFLY | May 15, 2014 | Substantially Equivalent |