Praywise Technology (Dongguan) Co., Ltd.
Registered establishment in Dongguan, Guangdong, China. 5 device types.
Praywise Technology (Dongguan) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Electrode, Cutaneous, Pad, Heating, Powered and 3 other device types. Its earliest product listing with the FDA dates from 2025.
Registration
| Registered name | PRAYWISE TECHNOLOGY (DONGGUAN) CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3042268484 |
| FEI number | 3042268484 |
| Establishment type | Manufacturer |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | Room 601,Building 10,No. 180, Maozhu Mountain Road |
| Postal code | 523000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Electrode, Cutaneous | Class 2 | 3-in-1 TENS/EMS device with heat; HIVOX OTC Electrical Stimulator, EM59-1; HIVOX OTC Electrical Stimulator, EM59-2 | 2025 | 47 |
| Media, Electroconductive | Class 2 | 3-in-1 TENS/EMS device with heat; HIVOX OTC Electrical Stimulator, EM59-1; HIVOX OTC Electrical Stimulator, EM59-2 | 2025 | 8 |
| Pad, Heating, Powered | Class 2 | Beurer; EM49 TENS/EMS Unit, HIVOX OTC Electrical Stimulator | 2025 | 144 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | stimulator, nerve, transcutaneous, over-the-counter – 3-in-1 TENS/EMS device with heat; HIVOX OTC Electrical Stimulator,, EM59-2, 3-in-1 TENS/EMS device with heat; HIVOX OTC Electrical Stimulator, EM59-1; HIVOX OTC Electrical Stimulator, EM59-2, HIVOX OTC Electrical Stimulator | 2025 | 66 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | stimulator, muscle, powered, for muscle conditioning – 3-in-1 TENS/EMS device with heat; HIVOX OTC Electrical Stimulator, EM59-2, Beurer; EM49 TENS/EMS Unit, stimulator, nerve, transcutaneous, over-the-counter – 3-in-1 TENS/EMS device with heat; HIVOX OTC Electrical Stimulator,, 3-in-1 TENS/EMS device with heat; HIVOX OTC Electrical Stimulator, EM59-1; HIVOX OTC Electrical Stimulator, EM59-2, HIVOX OTC Electrical Stimulator | 2025 | 57 |
Clearances
No clearance names Praywise Technology (Dongguan) Co., Ltd. as applicant. 7 are 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 |
|---|---|---|---|---|
| K232675 | 2023-10-05 | NUH | Special | Hivox Biotek Inc. |
| K223308 | 2023-05-13 | NUH | Traditional | Hivox Biotek Inc. |
| K221384 | 2022-06-11 | NUH | Special | Hivox Biotek Inc. |
| K211403 | 2021-10-15 | NUH | Traditional | Hivox Biotek Inc. |
| K203574 | 2021-03-10 | NUH | Traditional | Hivox Biotek Inc. |
| K190347 | 2019-03-15 | NUH | Special | Hivox Biotek Inc. |
| K131720 | 2014-07-25 | GXY | Traditional | Hivox Biotek Inc. |
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.
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