Data / Medical devices / Hong Kong / Nu-Tek Health (hongkong) Limited
Nu-Tek Health (hongkong) Limited: FDA-registered device maker in Kowloon Bay, Hong Kong, 4 510(k) clearances
Nu-Tek Health (hongkong) Limited is registered with the FDA (registration 3049809930) in Kowloon Bay, Hong Kong. It lists 9 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 5, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3049809930
- Address
- Unit 901B, 9/F, Tower II, Enterprise Square, No. 9 Sheung Yuet Road, Kowloon Bay, Hong Kong, 00000
- Owner or operator
- Nu-Tek Health (Hongkong) Limited (10096271)
- Roles
- Exporter to the US
- First device listed
- August 17, 2026
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Biofeedback | HCC | 2 | Exporter to the US | accessdata.fda.gov |
| Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | IMJ | 2 | Exporter to the US | accessdata.fda.gov |
| Interferential Current Therapy | LIH | 2 | Exporter to the US | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Exporter to the US | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Neuromuscular, External Functional | GZI | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | IMG | 2 | Exporter to the US | 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 5, 2024 | K240358 | ShockPhysio Mobile (model SW3200 Basic) | ISA | Substantially Equivalent | Shenzhen Dongdixin Technology Co., Ltd. | accessdata.fda.gov |
| November 13, 2015 | K150436 | ComboRehab | IMG | Substantially Equivalent | Shenzhen Dongdixin Technology Co., Ltd. | accessdata.fda.gov |
| March 14, 2014 | K131899 | SW-THERM | IMJ | Substantially Equivalent | Shenzhen Dongdixin Technology Co., Ltd. | accessdata.fda.gov |
| December 27, 2013 | K131259 | LASER-STIM | ILY | Substantially Equivalent | Shenzhen Dongdixin Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- All makers of Interferential Current Therapy
- All makers of Stimulator, Muscle, Powered
- All makers of Device, Biofeedback
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Updated June 5, 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.