Geko
FDA 510(k) K133638 · Firstkind Limited
510(k) numberK133638
Submission
- Device name
- Geko
- Applicant
- Firstkind Limited
West Boylston, MA, US - Received
- November 27, 2013
- Decision date
- August 21, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code IPF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253542 | Apollo Quattro (APQ-10M)IPF · Traditional | Weero Co., Ltd. | 06/08/2026SE |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP)IPF · Traditional | Mohammadali Nezakati | 06/02/2026SE |
| K260142 | StimelMD (SSMD) systemIPF · Special | Motion Informatics ltd. | 05/27/2026SE |
| K251083 | Compact IIIPF · Traditional | Enraf-Nonius, B.V. | 09/12/2025SE |
| K241433 | EVE Synergy (EVE-20M)IPF · Traditional | Weero Co., Ltd. | 06/04/2025SE |
| K241488 | TrainFES AdvanceIPF · Traditional | Trainfes | 02/05/2025SE |
| K240348 | Quantum Mitohormesis (QMT) (M2101)IPF · Abbreviated | Quantumtx Pte. , Ltd. | 12/19/2024SE |
| K240992 | eMVFit (MVF-10M)IPF · Traditional | Weero Co., Ltd. | 10/10/2024SE |
| 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 |
| K152677 | geko T-2 Neuromuscular StimulatorIPF · Special | 10/23/2015SE |
Questions and answers
When was Geko cleared by the FDA?
Geko (K133638) received a 510(k) decision of Substantially Equivalent on August 21, 2014, 267 days after the submission was received.
What is the product code of K133638?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.