HiDow HD-09G
HiDow HD-09G is a Class II device made by Hi-Dow International Inc., cleared under FDA 510(k) K210383 on 12 Nov 2021 and listed in FDA GUDID since 16 May 2022 (UDI-DI 00851640007870), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00851640007870 | Date16 May 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210383 | Date12 Nov 2021 | StatusActive |
Official records
- AccessGUDID record 00851640007870
- FDA 510(k) database K210383
Across registries
- FDA 510(k) K210383 decided 12 Nov 2021 Active
- FDA GUDID UDI-DI 00851640007870 listed 16 May 2022 Listed
Timeline
- Cleared FDA 510(k) K210383
- Listed FDA GUDID 00851640007870
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- HiDow
- Generic name
- Transcutaneous electrical stimulation electrode, reusable
- Model / reference
- HD-09G
- Primary DI / UDI-DI
- 00851640007870
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Transcutaneous electrical stimulation electrode, reusable
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code GXY (Electrode, Cutaneous).
- TENS-AID STERILE ELECTRODES FOR POST-OP TENS by Staodynamics, Inc.
- CONMED VERSA-STIM INTERFERENTIAL ELECTRODE by Conmedcorp
- AQUAFORM ELECTRODES WITH AQUAPORE by Biostim, Inc.
- BIS STANDARD SENSOR, 1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR, 1-CHANNEL, 3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR, 2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR, 4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR, CVI-ENABLED, 2-CHANNEL (4 ELECTRODES) by Covidien llc
- Element System with IBT Electrodes by Infinite Biomedical Technologies LLC
- Self-adhesive Electrode by DONG GUAN OU KANG ELECTRONICS CO.,LTD
- DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K by Medicotest, Inc.
- MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005 by Vermont Medical, Inc.
- WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP by Well-Life Healthcare, Inc.
- THERATRODE by Phoenix Medical Devices, Llp