Data / Medical devices / China / Hi-Dow Electron Technology (hefei) Inc., Ltd
Hi-Dow Electron Technology (hefei) Inc., Ltd: FDA-registered device maker in Hefei Anhui, China, 6 510(k) clearances
Hi-Dow Electron Technology (hefei) Inc., Ltd is registered with the FDA (registration 3010417025) in Hefei Anhui, China. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 19, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010417025
- Address
- Building D17/22, Baiyan Science & Technology Industrial Park No.168 XiangZhang Road, Hefei Anhui, China, 230088
- Owner or operator
- HI-DOW ELECTRON TECHNOLOGY (HEFEI) INC., LTD (10044091)
- Roles
- Manufacturer
- First device listed
- October 8, 2014
- Registered through
- 2026
- Brand names listed
- HIDOW Wireless TENS/EMS, Hi-Dow Pro Touch Wireless 6-12 (HD-19A), Hidow TENS/EMS, Pulsed Electromagnetic Field Wrap, Wrap Accessory Electrodes
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat | ILX | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 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 |
|---|---|---|---|---|---|---|
| January 19, 2024 | K233461 | Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) | NUH | Substantially Equivalent | Hi-Dow International, Inc. | accessdata.fda.gov |
| November 12, 2021 | K210383 | Wrap Accessory Electrodes | GXY | Substantially Equivalent | Hi-Dow International, Inc. | accessdata.fda.gov |
| December 15, 2020 | K202337 | Pulsed electromagnetic field wrap | ILX | Substantially Equivalent | Hi-Dow International, Inc. | accessdata.fda.gov |
| July 2, 2019 | K190617 | Wrap accessory electrodes | GXY | Substantially Equivalent | Hi-Dow International, Inc. | accessdata.fda.gov |
| August 4, 2017 | K163393 | Hi-Dow Wireless TENS/EMS System (Model HD-5N) | NUH | Substantially Equivalent | Hi-Dow International, Inc. | accessdata.fda.gov |
| May 13, 2011 | K102598 | HI-DOW-XP | NUH | Substantially Equivalent | Hi-Dow International, Inc. | accessdata.fda.gov |
Compare with other makers
- 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 Pad, Heating, Powered
- All makers of Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Updated January 19, 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.