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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 the device name listed in this FDA 510(k) record. The listed applicant is Heat IN A Click, LLC. It received FDA 510(k) clearance on 2020-08-28 under 510(k) 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. The listed applicant is Heat IN A Click, LLC. The 510(k) number is K191938.

When did FitRelief TENS&EMS Wireless Device receive FDA 510(k) clearance?

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

Who is the listed applicant for FitRelief TENS&EMS Wireless Device?

The FDA 510(k) record lists Heat IN A Click, LLC as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: NGX)

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Official Source

View on FDA Database →

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

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