Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003755374

FEI Number

3003755374

Entity Name

INNO-HEALTH TECHNOLOGY CO., LTD.

City/State/Country

Taichung City, TW

Establishment Address

No. 36, Jingke 8th Rd., Nantun Dist., Taichung City 408, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INNO-HEALTH TECHNOLOGY CO., LTD. (Owner Number: 9045314)

Owner / Operator Contact Address

No. 36, Jingke 8th Rd., Nantun Dist., Taichung City, TW-NOTA 408, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Transcutaneous Electrical Nerve Stimulator Transcutaneous Electrical Nerve Stimulator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2019-08-02
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2002-05-09
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2001-03-29
NZU	Collector, Urine, Powered, Non Indwelling Catheter	Gastroenterology, Urology	Class 1	876.5250	2012-01-16
BWK	Stimulator, Electro-Acupuncture	Unknown	Class U	N/A	2006-12-08
BWK	Stimulator, Electro-Acupuncture	Unknown	Class U	N/A	2010-04-07
INQ	Table, Powered	Physical Medicine	Class 1	890.3760	2007-03-09
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2012-01-12

Official Correspondent

TERRY CHIANG

US Agent Details

David Peng Business: ACULIFE USA, INC. Email: aculife.inno@msa.hinet.net Phone: (562) 8831144

Related Public Records

Same Entity

INNO-HEALTH TECHNOLOGY CO., LTD.

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
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17
K792659	Bio-Feedback Systems, Inc.	FEEDBACK EDR SYSTEM MODEL ME-1	1980-01-09
K791969	Medline Industries, Inc.	DYNACOR STERILE CLOSED SYS. DRAINAGE BAG	1979-11-05

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3011255064	RAYONEX BIOMEDICAL GMBH	Lennestadt North Rhine-Westphalia, DE
3038620647	KISO EHF	Reykjavik, IS
3005196642	HARMONIC ENERGETIC TECHNOLOGIES, LLC	Liverpool, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003755374. Last updated year: 2026. Please use registration number 3003755374 when referencing this establishment in official correspondence.