Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003895865

FEI Number

3003895865

Entity Name

HI-DOW INTERNATIONAL INC.

City/State/Country

Maryland Heights, MO, US

Establishment Address

2555 Metro Blvd, Maryland Heights, MO 63043, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Hi-Dow International Incorporated (Owner Number: 9052765)

Owner / Operator Contact Address

2555 Metro Blvd, --, Maryland Heights, MO 63043, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162663

PMA Number

N/A

All Registered Proprietary Names

Face Mask Pack, hot or cold, reusable Non-surgical isolation gown LED therapeutic torch MASSAGE MOUSE) ECHO Massager Electric Massager Percussion Massager & Massage Gun MULTIPLE(SBS Hidow TENS/EMS Painpod 3 Surgical N95 Respirator Hidow/Epic Health N95 Surgical Face Mask Disposable Medical Mask Disposable Face Mask Pro-Touch Wireless 6-12 PainPod ultra Nitrile Powder Free Examination Gloves

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2020-12-16
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2013-06-24
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2020-12-16
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-22
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2024-03-21
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-09
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2024-02-02
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2020-12-16
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2002-08-29
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2011-12-19
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2011-12-19
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-20
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2024-05-08
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2024-05-08
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-06-30
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2020-02-26
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2020-02-26

Official Correspondent

Eric Chen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hi-Dow International Incorporated

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
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

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3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003895865. Last updated year: 2026. Please use registration number 3003895865 when referencing this establishment in official correspondence.