firefly T-2
FDA 510(k) K201131 · Firstkind Limited
510(k) numberK201131
Submission
- Device name
- firefly T-2
- Applicant
- Firstkind Limited
High Wycombe, GB - Received
- April 28, 2020
- Decision date
- May 28, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NGX – Stimulator, Muscle, Powered, For Muscle Conditioning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this…
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| K191113 | geko T-2 and geko T-3 Neuromuscular StimulatorsIPF · Traditional | 09/18/2019SE |
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| K152677 | geko T-2 Neuromuscular StimulatorIPF · Special | 10/23/2015SE |
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Questions and answers
When was firefly T-2 cleared by the FDA?
firefly T-2 (K201131) received a 510(k) decision of Substantially Equivalent on May 28, 2020, 30 days after the submission was received.
What is the product code of K201131?
The FDA product code is NGX – Stimulator, Muscle, Powered, For Muscle Conditioning, a Class II (moderate risk) device regulated under 21 CFR 890.5850.