FDA 510(k)

ReliefBand

K-Number: K182960 · 2019-06-21

Decision Date2019-06-21

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ReliefBand is the device name listed in this FDA 510(k) record. The listed applicant is Reliefband Technologies, LLC. It received FDA 510(k) clearance on 2019-06-21 under 510(k) number K182960. 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 ReliefBand?

ReliefBand is a medical device that received FDA 510(k) clearance on 2019-06-21. The listed applicant is Reliefband Technologies, LLC. The 510(k) number is K182960.

When did ReliefBand receive FDA 510(k) clearance?

ReliefBand received FDA 510(k) clearance on 2019-06-21, under 510(k) number K182960.

Who is the listed applicant for ReliefBand?

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

What is the FDA product code for ReliefBand?

The FDA product code for ReliefBand is GZJ.

Other records listing Reliefband Technologies, LLC as applicant

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.

K191547ReliefBand K173233ReliefBand 1.5

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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.