FDA 510(k)

H-WAVE

K-Number: K112485 · 2011-12-06

Decision Date2011-12-06

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

H-WAVE is the device name listed in this FDA 510(k) record. The listed applicant is Electronic Waveform Lab, Inc.. It received FDA 510(k) clearance on 2011-12-06 under 510(k) number K112485. 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 H-WAVE?

H-WAVE is a medical device that received FDA 510(k) clearance on 2011-12-06. The listed applicant is Electronic Waveform Lab, Inc.. The 510(k) number is K112485.

When did H-WAVE receive FDA 510(k) clearance?

H-WAVE received FDA 510(k) clearance on 2011-12-06, under 510(k) number K112485.

Who is the listed applicant for H-WAVE?

The FDA 510(k) record lists Electronic Waveform Lab, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for H-WAVE?

The FDA product code for H-WAVE 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.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.