FDA 510(k)

TrueRelief Device

K-Number: K202186 · 2021-03-23

Decision Date2021-03-23

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TrueRelief Device is the device name listed in this FDA 510(k) record. The listed applicant is Truerelief. It received FDA 510(k) clearance on 2021-03-23 under 510(k) number K202186. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TrueRelief Device?

TrueRelief Device is a medical device that received FDA 510(k) clearance on 2021-03-23. The listed applicant is Truerelief. The 510(k) number is K202186.

When did TrueRelief Device receive FDA 510(k) clearance?

TrueRelief Device received FDA 510(k) clearance on 2021-03-23, under 510(k) number K202186.

Who is the listed applicant for TrueRelief Device?

The FDA 510(k) record lists Truerelief as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TrueRelief Device?

The FDA product code for TrueRelief Device is GZJ.

Related Devices (Code: GZJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimed K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical Officer K233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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.