geko T-2 Neuromuscular Stimulator
FDA 510(k) K152677 · Firstkind Limited
510(k) numberK152677
Submission
- Device name
- geko T-2 Neuromuscular Stimulator
- Applicant
- Firstkind Limited
High Wycombe, GB - Received
- September 18, 2015
- Decision date
- October 23, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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| K240234 | BTL-899MSIPF · Traditional | BTL Industries, Inc. | 08/17/2024SE |
| K233098 | MYOTouch Muscle StimulatorIPF · Traditional | Sunmed, LLC | 08/02/2024SE |
More from Sunmed, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K220327 | geko W-3IPF · Special | 03/04/2022SE |
| K212762 | geko W-2IPF · Traditional | 11/29/2021SE |
| K201131 | firefly T-2NGX · Special | 05/28/2020SE |
| K193045 | geko W-2IPF · Special | 01/18/2020SE |
| K191113 | geko T-2 and geko T-3 Neuromuscular StimulatorsIPF · Traditional | 09/18/2019SE |
| K181059 | geko T-3 Neuromuscular StimulatorIPF · Special | 05/23/2018SE |
| K180082 | geko T-2 and geko Plus R-2IPF · Traditional | 02/11/2018SE |
| K163125 | geko T-2 and geko Plus R-2 Neuromuscular StimulatorsIPF · Traditional | 04/10/2017SE |
| K160299 | geko(TM) Plus R-2 Neuromuscular StimulatorIPF · Special | 04/08/2016SE |
| K133638 | GekoIPF · Traditional | 08/21/2014SE |
Questions and answers
When was geko T-2 Neuromuscular Stimulator cleared by the FDA?
geko T-2 Neuromuscular Stimulator (K152677) received a 510(k) decision of Substantially Equivalent on October 23, 2015, 35 days after the submission was received.
What is the product code of K152677?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.