Data / Medical devices / China / Gymmax Technology Shenzhen Co., Ltd
Gymmax Technology Shenzhen Co., Ltd: FDA-registered device maker in Shenzhen City Guangdong, China, 3 510(k) clearances
Gymmax Technology Shenzhen Co., Ltd is registered with the FDA (registration 3007689716) in Shenzhen City Guangdong, China. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 10, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007689716
- Address
- 4F&5F, 4th Bldg, Heping Complex (4th Bldg. Huimingsheng Technology Park) Fuhai Subdistrict, Baoan District, Shenzhen City Guangdong, China, 518103
- Owner or operator
- GYMMAX TECHNOLOGY SHENZHEN CO., LTD. (10027514)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 22, 2011
- Registered through
- 2026
- Brand names listed
- Versatone, Versatone Gen II, Flextone,
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Contract manufacturer | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Contract manufacturer | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Contract manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | 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 |
|---|---|---|---|---|---|---|
| June 10, 2024 | K240108 | Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01) | GXY | Substantially Equivalent | Gymmax Technology Shenzhen Co., Ltd. | accessdata.fda.gov |
| March 21, 2024 | K232439 | Electrical Stimulator System | NUH | Substantially Equivalent | Gymmax Technology Shenzen Co., Ltd. | accessdata.fda.gov |
| June 12, 2020 | K192201 | Electrical Stimulator System | NUH | Substantially Equivalent | Gymmax Technology Shenzen Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Over-The-Counter Powered Light Based Laser For Acne
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Electrode, Cutaneous
- All makers of Lamp, Infrared, Therapeutic Heating
Updated June 10, 2024. 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.