Data / Medical devices / China / Praywise Technology (dongguan) Co., Ltd
Praywise Technology (dongguan) Co., Ltd: FDA-registered device maker in Dongguan City Guangdong, China, 7 510(k) clearances
Praywise Technology (dongguan) Co., Ltd is registered with the FDA (registration 3042268484) in Dongguan City Guangdong, China. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated October 5, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042268484
- Address
- Room 601,Building 10,No. 180, Maozhu Mountain Road Changping Town, Dongguan City Guangdong, China, 523000
- Owner or operator
- Praywise Technology (Dongguan) Co., Ltd (10094303)
- Roles
- Manufacturer
- First device listed
- November 21, 2025
- Registered through
- 2026
- Brand names listed
- 3-in-1 TENS/EMS device with heat; HIVOX OTC Electrical Stimulator, EM59-1; HIVOX OTC Electrical Stimulator, EM59-2, Beurer; EM49 TENS/EMS Unit, EM59-2, HIVOX OTC Electrical Stimulator, stimulator, muscle, powered, for muscle conditioning - 3-in-1 TENS/EMS device with heat; HIVOX OTC Electrical Stimulator, stimulator, nerve, transcutaneous, over-the-counter - 3-in-1 TENS/EMS device with heat; HIVOX OTC Electrical Stimulator,
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Manufacturer | accessdata.fda.gov |
| Media, Electroconductive | GYB | 2 | Manufacturer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 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 |
|---|---|---|---|---|---|---|
| October 5, 2023 | K232675 | Heating Tens, FT-615 | NUH | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| May 13, 2023 | K223308 | HEATING TENS/EMS, FT-810R | NUH | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| June 11, 2022 | K221384 | Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 | NUH | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| October 15, 2021 | K211403 | HIVOX OTC Electrical Stimulator, FT610-B | NUH | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| March 10, 2021 | K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 | NUH | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| March 15, 2019 | K190347 | HIVOX OTC Electrical Stimulator | NUH | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
| July 25, 2014 | K131720 | HIVOX SELF ADHESIVE ELECTRODE GEL PADS | GXY | Substantially Equivalent | Hivox Biotek, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Cutaneous
- All makers of Media, Electroconductive
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Pad, Heating, Powered
Updated October 5, 2023. 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.