Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011506263

FEI Number

3011506263

Entity Name

DONG GUAN TUTAMEN METALWORKS CO, LTD.

City/State/Country

Dong Guan Guangdong, CN

Establishment Address

7th Floor, Building 2, Lishi Industrial park,No.26, Keyuan Rd., Tangxia Town, Dong Guan Guangdong 523725, CN

Establishment Type(s)

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

Owner / Operator

Dong Guan Tutamen Metalworks Co, Ltd. (Owner Number: 10052219)

Owner / Operator Contact Address

No.3 HuangGuoTang Rd., ShaHu,Tangxia Town, Dong Guan, CN-GD 523725, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201431

PMA Number

N/A

All Registered Proprietary Names

Progressive ROM Ortho Guards Ortho Guards Progressive ROM Ortho Guards Progressive ROM Richmar Hydratherm Spartan TAG Boot IWALK3 - Hands Free Crutch OGYILI TENS/NMES Stimulator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2017-01-09
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2022-01-17
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2016-06-30
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2016-06-30
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2016-06-30
IRQ	Unit, Heating, Powered	Physical Medicine	Class 1	890.5950	2023-11-28
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2019-07-26
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2016-08-05
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2022-07-22

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Dong Guan Tutamen Metalworks 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
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

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3038623066	WUYI KINDA INDUSTRY & TRADE CO., LTD	JINHUA Zhejiang, CN
3008351005	Care&Care Health Products Co., Ltd	Yuanli Township Miaoli, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011506263. Last updated year: 2026. Please use registration number 3011506263 when referencing this establishment in official correspondence.