The Electrode Store SH-96S
by Impulse Medical Technologies, Inc.
The Electrode Store SH-96S is a Class II device made by Impulse Medical Technologies, Inc., cleared under FDA 510(k) K022197 on 13 Aug 2002 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00816022020427), 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 | Number00816022020427 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK022197 | Date13 Aug 2002 | StatusActive |
Official records
- AccessGUDID record 00816022020427
- FDA 510(k) database K022197
Across registries
- FDA 510(k) K022197 decided 13 Aug 2002 Active
- FDA GUDID UDI-DI 00816022020427 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K022197
- Listed FDA GUDID 00816022020427
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- The Electrode Store
- Generic name
- Analytical scalp electrode, reusable
- Model / Ref / Catalog
- SH-96S
- Primary DI / UDI-DI
- 00816022020427
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Analytical scalp electrode, reusable
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
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