Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004558433

FEI Number

3004558433

Entity Name

BIOWAVE CORPORATION

City/State/Country

NORWALK, CT, US

Establishment Address

8 Knight St Ste 201, NORWALK, CT 06851, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

BIOWAVE CORPORATION (Owner Number: 9086399)

Owner / Operator Contact Address

19 Newtown Turnpike, --, Westport, CT 06880, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K072123

PMA Number

N/A

All Registered Proprietary Names

BioWaveHOME BioWaveGO Rx BioWavePENS BioWaveGO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2007-12-08
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2015-11-19
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2021-07-26
NHI	Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief	Neurology	Class 2	882.5890	2007-04-10
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2007-04-10
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2019-12-18
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2008-10-08

Official Correspondent

Bradford Siff

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOWAVE CORPORATION

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
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13

Similar Registrations

Registration Number	Establishment Name	Location
3012316249	COMPASS HEALTH BRANDS (CORPORATE OFFICE)	Middleburg Heights, OH, US
3010805941	BIO PROTECH YANTAI INC	Yantai Shandong, CN
3014315574	BRH MEDICAL LTD	Jerusalem, IL
9615033	FUJI DYNAMICS LIMITED	Dongguan Guangdong, CN
3004049909	EASYMED INSTRUMENTS CO., LTD.	Daliang, Shunde, Foshan Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004558433. Last updated year: 2026. Please use registration number 3004558433 when referencing this establishment in official correspondence.