FitRelief TENS&EMS Wireless Device
FDA 510(k) K191938 · Heat IN A Click, LLC
510(k) numberK191938
Submission
- Device name
- FitRelief TENS&EMS Wireless Device
- Applicant
- Heat IN A Click, LLC
Dania, FL, US - Received
- July 19, 2019
- Decision date
- August 28, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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Questions and answers
When was FitRelief TENS&EMS Wireless Device cleared by the FDA?
FitRelief TENS&EMS Wireless Device (K191938) received a 510(k) decision of Substantially Equivalent on August 28, 2020, 406 days after the submission was received.
What is the product code of K191938?
The FDA product code is NGX – Stimulator, Muscle, Powered, For Muscle Conditioning, a Class II (moderate risk) device regulated under 21 CFR 890.5850.