FDA Registration
Active
🇨🇳 China
PRAYWISE TECHNOLOGY (DONGGUAN) CO., LTD
Reg #: 3042268484
·
FEI: 3042268484
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- PRAYWISE TECHNOLOGY (DONGGUAN) CO., LTD
- Registration Number
- 3042268484
- FEI Number
- 3042268484
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 601,Building 10,No. 180, Maozhu Mountain Road, Changping Town
- City
- Dongguan City Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K221384
Owner / Operator
- Firm Name
- Praywise Technology (Dongguan) Co., Ltd
- Operator Number
- 10094303
- Address
- Room 601,Building 10,No. 180, Maozhu Mountain Road, Changping Town
- City
- Dongguan City
- State
- Guangdong
- Postal Code
- 523000
- Country
- CN
US Agent
- Business Name
- Registrar corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2025-11-21 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2025-11-21 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2025-11-21 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2025-11-21 |
| Media, Electroconductive | GYB | Class 2 | Neurology | No | 2025-11-21 |
Proprietary Names
HIVOX OTC Electrical Stimulator
3-in-1 TENS/EMS device with heat; HIVOX OTC Electrical Stimulator, EM59-1; HIVOX OTC Electrical Stimulator, EM59-2
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,
Establishment Types
Manufacture Medical Device