HI-DOW Electron Technology (Hefei) Inc., Ltd
Registered establishment in Hefei, Anhui, China. 5 device types.
HI-DOW Electron Technology (Hefei) Inc., 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 2014.
Registration
| Registered name | HI-DOW ELECTRON TECHNOLOGY (HEFEI) INC., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010417025 |
| FEI number | 3010417025 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 高健电子科技（合肥）股份有限公司 |
|---|---|
| Source | Tianyancha company register |
Location
| City | Hefei |
|---|---|
| Province | Anhui |
| Address | Building D17/22, Baiyan Science & Technology Industrial Park |
| Postal code | 230088 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat | Class 2 | Pulsed Electromagnetic Field Wrap | 2021 | 1 |
| Electrode, Cutaneous | Class 2 | Wrap Accessory Electrodes | 2019 | 47 |
| Pad, Heating, Powered | Class 2 | Pulsed Electromagnetic Field Wrap | 2021 | 144 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | Hi-Dow Pro Touch Wireless 6-12 (HD-19A), HIDOW Wireless TENS/EMS, Hidow TENS/EMS | 2014 | 66 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | Hi-Dow Pro Touch Wireless 6-12 (HD-19A), HIDOW Wireless TENS/EMS, Hidow TENS/EMS | 2014 | 57 |
Clearances
No clearance names HI-DOW Electron Technology (Hefei) Inc., Ltd as applicant. 6 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 |
|---|---|---|---|---|
| K233461 | 2024-01-19 | NUH | Traditional | HI-DOW International Inc. |
| K210383 | 2021-11-12 | GXY | Traditional | HI-DOW International Inc. |
| K202337 | 2020-12-15 | ILX | Traditional | HI-DOW International Inc. |
| K190617 | 2019-07-02 | GXY | Traditional | HI-DOW International Inc. |
| K163393 | 2017-08-04 | NUH | Traditional | HI-DOW International Inc. |
| K102598 | 2011-05-13 | NUH | Traditional | HI-DOW International Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | TENS EMS therapy devices, Wireless pulse systems, Pain management devices |
|---|
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.
The manufacturer named here can complete this record.