Dongguan Tutamen Metalwork Co., Ltd.
Registered establishment in Dongguan, Guangdong, China. 12 device types, 2 clearances.
Dongguan Tutamen Metalwork Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Crutch, Support, Arm and 10 other device types. Its earliest product listing with the FDA dates from 2016.
Registration
| Registered name | Dongguan Tutamen Metalwork Co.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011506263 |
| FEI number | 3011506263 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 东莞彩美金属制品有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | 7th Floor, Building 2, Lishi Industrial park,No.26, Keyuan Rd. |
| Postal code | 523710 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Crutch | Class 1 | iwalk 3 Crutch Assembly, IWALK3 – Hands Free Crutch | 2021 | 112 |
| Electrode, Cutaneous | Class 2 | 2026 | 47 | |
| Exerciser, Non-Measuring | Class 1 | Spartan | 2019 | 82 |
| Joint, Ankle, External Brace | Class 1 | Ortho Guards, Progressive ROM | 2016 | 134 |
| Joint, Knee, External Brace | Class 1 | Ortho Guards, Progressive ROM | 2016 | 137 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | 2022 | 235 | |
| Laser, Comb, Hair | Class 2 | 2026 | 30 | |
| Orthosis, Limb Brace | Class 1 | TAG Boot, IWALK3 – Hands Free Crutch | 2016 | 144 |
| Stand, Infusion | Class 1 | 2017 | 75 | |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | Class 2 | OGYILI TENS/NMES Stimulator | 2022 | 32 |
| Support, Arm | Class 1 | Progressive ROM, Ortho Guards | 2016 | 72 |
| Unit, Heating, Powered | Class 1 | Richmar Hydratherm | 2023 | 19 |
Clearances
2 clearances name Dongguan Tutamen Metalwork Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252439 | 2026-05-01 | GXY | Traditional | This company |
| K240472 | 2024-10-11 | OAP | Traditional | This company |
| K201431 | 2020-11-09 | GZJ | Traditional | Gongguan Tutamen Metalwork Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Employees | 850 |
| Main products | Liquid cooling plates, Heat sinks, Manifold and plumbing systems, Chassis and structural components, Thermal interface materials |
| Certifications | ISO 9001:2015, ISO 13485:2016, ISO 14001:2015 |
| Export markets | Global |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.