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FDA 510(k)

FitRelief TENS&EMS Wireless Device

K-Number: K191938 · 2020-08-28

ApplicantHeat IN A Click, LLC
Decision Date2020-08-28
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FitRelief TENS&EMS Wireless Device is a medical device manufactured by Heat IN A Click, LLC. It received FDA 510(k) clearance on 2020-08-28 under approval number K191938. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FitRelief TENS&EMS Wireless Device?

FitRelief TENS&EMS Wireless Device is a medical device that received FDA 510(k) clearance on 2020-08-28. It is manufactured by Heat IN A Click, LLC. The 510(k) number is K191938.

When was FitRelief TENS&EMS Wireless Device approved by the FDA?

FitRelief TENS&EMS Wireless Device received FDA 510(k) clearance on 2020-08-28, under approval number K191938.

What company makes FitRelief TENS&EMS Wireless Device?

FitRelief TENS&EMS Wireless Device is manufactured by Heat IN A Click, LLC.

What is the FDA product code for FitRelief TENS&EMS Wireless Device?

The FDA product code for FitRelief TENS&EMS Wireless Device is NGX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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