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FDA 510(k)

DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE

K-Number: K052289 · 2005-12-13

ApplicantBiowave Corporation
Decision Date2005-12-13
Product CodeLIH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DEEPWAVE NEUROMODULATION 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 2005-12-13 under 510(k) number K052289. The device is classified under product code LIH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE?

DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE is a medical device that received FDA 510(k) clearance on 2005-12-13. The listed applicant is Biowave Corporation. The 510(k) number is K052289.

When did DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE receive FDA 510(k) clearance?

DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE received FDA 510(k) clearance on 2005-12-13, under 510(k) number K052289.

Who is the listed applicant for DEEPWAVE NEUROMODULATION 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 DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE?

The FDA product code for DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE is LIH.

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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 RXK180943BioWaveGOK072123HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICEK061166DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM

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Related Devices (Code: LIH)

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.

K231575Vecttor VT-300Artaflex, Inc.K202725ETD4000Therasigma, LLCK183692Avid IF2Vision Quest Industries Inc./Dba VQ OrthocareK122944GEMORE TRUE SINE INTERFERENTIAL STIMULATORGemore Technology Co, Ltd.K121662VECTTOR VT-200Alan Neuromedical Technologies, LLCK110509EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908Everyway Medical Instruments Co.,Ltd

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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