Data / Medical devices / United States / Electronic Waveform Lab, Inc.

Electronic Waveform Lab, Inc.: FDA-registered device maker in Huntingtn Bch, CA, United States, 7 510(k) clearances

Name: Electronic Waveform Lab, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Electronic Waveform Lab, Inc. is registered with the FDA (registration 2023152) in Huntingtn Bch, CA, United States. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 15, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2023152
Address: 5702 Bolsa Ave, Huntingtn Bch, CA, United States, 92649
Owner or operator: ELECTRONIC WAVEFORM LABORATORY, INC. (2023152)
Roles: Manufacturer, Specification developer
First device listed: January 3, 2008
Registered through: 2026
Brand names listed: H-Wave, H-Wave OTC

Devices it lists

Device	Product code	Class	Role	Source
Device, Electrical Dental Anesthesia	LWM	U	Specification developer	accessdata.fda.gov
Device, Muscle Monitoring	KZM	2	Specification developer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Manufacturer, Specification developer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Manufacturer, Specification developer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 15, 2016	K160255	HBOTC Muscle and Nerve Stimulator	NUH	Substantially Equivalent	Hb Medical, Inc.	accessdata.fda.gov
December 6, 2011	K112485	H-WAVE	GZJ	Substantially Equivalent	Electronic Waveform Lab, Inc.	accessdata.fda.gov
June 1, 2011	K103738	H-WAVE	IPF	Substantially Equivalent	Electronic Waveform Laboratory, Inc.	accessdata.fda.gov
May 8, 1992	K915230	H WAVE MUSCLE STIMULATOR	IPF	Substantially Equivalent	Electronic Waveform Laboratory, Inc.	accessdata.fda.gov
April 12, 1988	K873604	E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY	LWM	Substantially Equivalent	Electronic Waveform Laboratory, Inc.	accessdata.fda.gov
June 17, 1987	K862121	E.W.L. P-TENS/H-WAVE	KZM	Substantially Equivalent	Electronic Waveform Laboratory, Inc.	accessdata.fda.gov
March 19, 1982	K813601	E.W.L. P-TENS MODEL(TENS	GZJ	Substantially Equivalent	Electronic Waveform Laboratory, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 15, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.