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FDA 510(k)

H-WAVE

K-Number: K103738 · 2011-06-01

ApplicantElectronic Waveform Laboratory, Inc.
Decision Date2011-06-01
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

H-WAVE is the device name listed in this FDA 510(k) record. The listed applicant is Electronic Waveform Laboratory, Inc.. It received FDA 510(k) clearance on 2011-06-01 under 510(k) number K103738. The device is classified under product code IPF. It was reviewed by the PM 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 2011-06-01. The listed applicant is Electronic Waveform Laboratory, Inc.. The 510(k) number is K103738.

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

H-WAVE received FDA 510(k) clearance on 2011-06-01, under 510(k) number K103738.

Who is the listed applicant for H-WAVE?

The FDA 510(k) record lists Electronic Waveform Laboratory, 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 IPF.

Other records listing Electronic Waveform Laboratory, Inc. 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.

K081998H-WAVE SPORTK915230H WAVE MUSCLE STIMULATORK873604E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRYK862121E.W.L. P-TENS/H-WAVEK813601E.W.L. P-TENS MODEL(TENS

Related Devices (Code: IPF)

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.

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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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