Sys*Stim 228 ME 228
Sys*Stim 228 ME 228 is a medical device (FDA Class II) made by Mettler Electronics Corp., cleared under FDA 510(k) K964028 on 3 Feb 1997 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 00816864020159), 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 | Number00816864020159 | Date15 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK964028 | Date3 Feb 1997 | StatusActive |
Official records
- AccessGUDID record 00816864020159
- FDA 510(k) database K964028
Across registries
- FDA 510(k) K964028 decided 3 Feb 1997 Active
- FDA GUDID UDI-DI 00816864020159 listed 15 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K964028
- Listed FDA GUDID 00816864020159
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sys*Stim 228
- Generic name
- Physical therapy transcutaneous electrical stimulation system, line-powered
- Model / Ref / Catalog
- ME 228
- Primary DI / UDI-DI
- 00816864020159
- 510(k) Number
- FDA product code
- LIH, IPF
- GMDN term
- Physical therapy transcutaneous electrical stimulation system, line-powered
- Device class
- Class II
- Regulation number
- 882.5890, 890.5850
- GUDID distribution status
- In Commercial Distribution
- Size
- Weight — 4.9 Pound
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- EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 by EVERYWAY MEDICAL INSTRUMENTS CO., LTD.