Reusable Cutaneous Electrode
by Ampcare, LLC
510(k) K121483
Reusable Cutaneous Electrode is a Class II device made by Ampcare, LLC, cleared under FDA 510(k) K121483 on 15 Oct 2012, 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 | NumberK121483 | Date15 Oct 2012 | StatusActive |
Official records
- FDA 510(k) database K121483
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- Withdrawn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
Devices cleared under K121483
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| E Series 50709LT | 50709LT / 50709LT | 00867786000200 | — | On the market |
| E Series 50709ST | 50709ST / 50709ST | 00867786000217 | — | On the market |
Similar devices
Other devices filed under FDA product code GXY (Electrode, Cutaneous).
- VALUETRODE by AXELGAARD MFG. CO., LTD.
- CHIN ELECTRODE by Dymedix, Inc.
- CANMED 103 by MEDTRONIC VASCULAR, INC.
- ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES by Prizm Medical, Inc.
- ELECTROLINK by Kold Products
- myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) by Otto Bock Healthcare Products GmbH
- MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE by Rhythmlink International, LLC
- COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE by COLUMBIA SCIENTIFIC DEVELOPMENT, LLC
- PROMONTORY STIMULATING ELECTRODE by Cadwell Laboratories, Inc.
- Sanibel TM electrode by Interacoustics A/S