ELECTRONIC WAVEFORM LAB, INC.

FDA Device Registration & Listing · Huntingtn Bch, CA, US · Registration 2023152

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2023152
FEI Number
2023152
Entity Name
ELECTRONIC WAVEFORM LAB, INC.
City/State/Country
Huntingtn Bch, CA, US
Establishment Address
5702 Bolsa Ave, Huntingtn Bch, CA 92649, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ELECTRONIC WAVEFORM LABORATORY, INC. (Owner Number: 2023152)
Owner / Operator Contact Address
5702 Bolsa Ave, --, Huntington Beach, CA 92649, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K103738
PMA Number
N/A

All Registered Proprietary Names

H-Wave OTC H-Wave H-Wave H-Wave H-Wave H-Wave

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2017-11-09
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2017-11-09
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2017-11-09
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2008-01-03
LWM Device, Electrical Dental Anesthesia Unknown Class U N/A 2008-01-03
KZM Device, Muscle Monitoring Physical Medicine Class 2 890.1375 2008-01-03
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2013-01-16
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2011-12-27

Official Correspondent

W. HEANEY

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ELECTRONIC WAVEFORM LABORATORY, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K030403 Cefar Medical AB CEFAR REHAB 2 AND REHAB 2 PRO 2003-07-17
K231440 Shenzhen Roundwhale Technology Co. , Ltd. Combo Electrotherapy Device 2023-11-03
K820884 Nitron Electronics ELECTRICAL MUSCLE STIMULATOR 1982-04-29
K201958 Therasigma, LLC ETD Family of Electrotherapy Devices 2020-08-04
K964028 Mettler Electronics Corp. SYS STIM 226 1997-02-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2023152. Last updated year: 2026. Please use registration number 2023152 when referencing this establishment in official correspondence.
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