Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616309

FEI Number

3003750857

Entity Name

TEN COMFORT CORP.

City/State/Country

New Taipei City, TW

Establishment Address

6F-3, No. 213, Fu-Ho Road, Yung-Ho District, New Taipei City 23450, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

TEN COMFORT CORP. (Owner Number: 9038541)

Owner / Operator Contact Address

6F-3, No. 213, Fu-Ho Road, Yung-Ho District, New Taipei City, TW-TPE 23450, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TEN COMFORT ELECTRONIC MASSAGER Disposable Scope Warmer, Clear Scope Kit Battery-Powered Transilluminator PURECARE AT-903 TENS HOTPAD HOT PACK COMPRESS TEN COMFORT COLD Presurgical Hot / Cold Pad

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2001-01-08
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2012-12-14
HJN	Transilluminator, Battery-Powered	Ophthalmic	Class 1	886.1945	2010-01-11
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2008-12-30
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2007-12-14
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2001-01-22
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2010-02-09

Official Correspondent

No official correspondent registered.

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

TEN COMFORT CORP.

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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

Similar Registrations

Registration Number	Establishment Name	Location
3016460723	ZHEJIANG AOLIN INDUSTRY & TRADE CO., LTD.	Lishui Zhejiang, CN
3032903908	TECHDERM LLC	Palm Beach Gardens, FL, US
3030407739	CL MEDIX INC	Chantilly, VA, US
3009079475	Aerotel Ltd.	Holon Central, IL
3025350087	LENYO WORLD LTD	Budapest, HU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616309. Last updated year: 2026. Please use registration number 9616309 when referencing this establishment in official correspondence.