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FDA 510(k)

HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE

K-Number: K072123 · 2008-02-01

ApplicantBiowave Corporation
Decision Date2008-02-01
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Biowave Corporation. It received FDA 510(k) clearance on 2008-02-01 under 510(k) number K072123. 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 HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE?

HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE is a medical device that received FDA 510(k) clearance on 2008-02-01. The listed applicant is Biowave Corporation. The 510(k) number is K072123.

When did HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE receive FDA 510(k) clearance?

HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE received FDA 510(k) clearance on 2008-02-01, under 510(k) number K072123.

Who is the listed applicant for HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE?

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 HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE?

The FDA product code for HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE is GZJ.

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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 BioWrapsK203158BioWave BioWrapsK210202BioWaveGO RXK180943BioWaveGOK061166DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEMK052289DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE

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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 miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical 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.

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