FDA 510(k)

TENSWave

K-Number: K241228 · 2024-08-27

Decision Date2024-08-27

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TENSWave is the device name listed in this FDA 510(k) record. The listed applicant is Zynex Medical Officer. It received FDA 510(k) clearance on 2024-08-27 under 510(k) number K241228. 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 TENSWave?

TENSWave is a medical device that received FDA 510(k) clearance on 2024-08-27. The listed applicant is Zynex Medical Officer. The 510(k) number is K241228.

When did TENSWave receive FDA 510(k) clearance?

TENSWave received FDA 510(k) clearance on 2024-08-27, under 510(k) number K241228.

Who is the listed applicant for TENSWave?

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

What is the FDA product code for TENSWave?

The FDA product code for TENSWave 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.K233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited K222879Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)Wuxi Jiajian Medical Instrument Co., Ltd.

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.