Wrap accessory electrodes
by Hi-Dow International, Inc. 2 variants
510(k) K190617
Wrap accessory electrodes is a medical device (FDA Class II; FDA product code GXY, Electrode, Cutaneous) made by Hi-Dow International, Inc., cleared under FDA 510(k) K190617 on 2 Jul 2019, 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 | FDA 510(k)SESE | NumberK190617 | Date2 Jul 2019 | StatusActive |
Official records
- FDA 510(k) database K190617
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GXY
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1320
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code GXY (Electrode, Cutaneous).
- Ceribell Instant EEG Headband by Ceribell, Inc.
- Reusable Finger Clip Recording Electrode by Chalgren Enterprises, Inc.
- VALUTRODE NEUROSTIMLATION ELECTRODES by AXELGAARD MFG. CO., LTD.
- Ascend Electrode by NEUROMETRIX, INC.
- Aspect Medical Systems Pediatric Bis Eeg Sensor, Model 186-0110 by Aspect Medical Systems, Inc.
- AQUABOND Electrode by Medibond, Ltd.
- Spare MS 700 Tens Electrode by Lectec Corp.
- Hivox Self Adhesive Electrode Gel Pads by HIVOX BIOTEK INC.
- Garment Electrodes by Shenzhen Dongdixin Technology Co., Ltd.
- Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe by SHENZHEN ROUNDWHALE TECHNOLOGY CO. LTD.