Data / Medical devices / China / Dongguan Tutamen Metalwork Co.,LTD.
Dongguan Tutamen Metalwork Co.,LTD.: FDA-registered device maker in Dongguan Guangdong, China, 3 510(k) clearances
Dongguan Tutamen Metalwork Co.,LTD. is registered with the FDA (registration 3011506263) in Dongguan Guangdong, China. It lists 12 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 1, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3011506263
- Address
- 7th Floor, Building 2, Lishi Industrial park,No.26, Keyuan Rd. Tangxia Town, Dongguan Guangdong, China, 523710
- Owner or operator
- Dong Guan Tutamen Metalworks Co, Ltd. (10052219)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- June 30, 2016
- Registered through
- 2027
- Brand names listed
- IWALK3 - Hands Free Crutch, OGYILI TENS/NMES Stimulator, Ortho Guards, Progressive ROM, Richmar Hydratherm, Spartan, TAG Boot, iwalk 3 Crutch Assembly
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crutch | IPR | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Exerciser, Non-Measuring | ION | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Joint, Ankle, External Brace | ITW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Laser, Comb, Hair | OAP | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Support, Arm | IOY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Heating, Powered | IRQ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 1, 2026 | K252439 | Tutamen Self Adhesive Electrodes | GXY | Substantially Equivalent | Dongguan Tutamen Metalwork Co., Ltd. | accessdata.fda.gov |
| October 11, 2024 | K240472 | PBM Hair Therapy Cap | OAP | Substantially Equivalent | Dongguan Tutamen Metalwork Co., Ltd. | accessdata.fda.gov |
| November 9, 2020 | K201431 | OGYILI TENS/NMES Stimulator | GZJ | Substantially Equivalent | Gongguan Tutamen Metalwork Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Exerciser, Non-Measuring
- All makers of Electrode, Cutaneous
- All makers of Orthosis, Limb Brace
- All makers of Crutch
- All makers of Joint, Knee, External Brace
- All makers of Stand, Infusion
Updated May 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.