Electro-Mesh Panel EMSP48
Electro-Mesh Panel EMSP48 is a transcutaneous electrical stimulation electrode (FDA Class II; FDA product code GXY, Electrode, Cutaneous) made by Prizm Medical, Inc., cleared under FDA 510(k) K944487 on 21 Feb 1995 and listed in FDA GUDID since 6 Jun 2024 (UDI-DI B872EMSP480), active as of 23 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 | NumberB872EMSP480 | Date6 Jun 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK944487 | Date21 Feb 1995 | StatusActive |
Official records
- FDA 510(k) database K944487
Across registries
- FDA 510(k) K944487 decided 21 Feb 1995 Active
- FDA GUDID UDI-DI B872EMSP480 listed 6 Jun 2024 Listed
Timeline
- Cleared FDA 510(k) K944487
- Listed FDA GUDID B872EMSP480
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Electro-Mesh Panel
- Generic name
- Transcutaneous electrical stimulation electrode, single-use
- Model / reference
- EMSP48
- Primary DI / UDI-DI
- B872EMSP480
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Transcutaneous electrical stimulation electrode, single-use
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
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