The Electrode Store AWM-2.00
by Impulse Medical Technologies, Inc.
The Electrode Store AWM-2.00 is a Class II device made by Impulse Medical Technologies, Inc., cleared under FDA 510(k) K926094 on 6 Dec 1995 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00816022022322), 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 | Number00816022022322 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK926094 | Date6 Dec 1995 | StatusActive |
Official records
- AccessGUDID record 00816022022322
- FDA 510(k) database K926094
Across registries
- FDA 510(k) K926094 decided 6 Dec 1995 Active
- FDA GUDID UDI-DI 00816022022322 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K926094
- Listed FDA GUDID 00816022022322
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- The Electrode Store
- Generic name
- Electromyographic needle electrode, single-use
- Model / Ref / Catalog
- AWM-2.00
- Primary DI / UDI-DI
- 00816022022322
- 510(k) Number
- FDA product code
- GXZ
- GMDN term
- Electromyographic needle electrode, single-use
- Device class
- Class II
- Regulation number
- 882.1350
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Electromyographic needle electrode, single-use.