FDA 510(k)

BioWaveGO

K-Number: K180943 · 2018-08-17

Decision Date2018-08-17

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

BioWaveGO is the device name listed in this FDA 510(k) record. The listed applicant is Biowave Corporation. It received FDA 510(k) clearance on 2018-08-17 under 510(k) number K180943. 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 BioWaveGO?

BioWaveGO is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is Biowave Corporation. The 510(k) number is K180943.

When did BioWaveGO receive FDA 510(k) clearance?

BioWaveGO received FDA 510(k) clearance on 2018-08-17, under 510(k) number K180943.

Who is the listed applicant for BioWaveGO?

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

What is the FDA product code for BioWaveGO?

The FDA product code for BioWaveGO is GZJ.

Other records listing Biowave Corporation 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.

K261522BioWave BioWraps K203158BioWave BioWraps K210202BioWaveGO RX

Related Devices (Code: GZJ)

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

View on FDA Database →

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