Sys Stim 226
510(k) K964028
Sys Stim 226 is a medical device (FDA Class II; FDA product code IPF, Stimulator, Muscle, Powered) made by Mettler Electronics Corp., cleared under FDA 510(k) K964028 on 3 Feb 1997, 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 | NumberK964028 | Date3 Feb 1997 | StatusActive |
Official records
- FDA 510(k) database K964028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IPF
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K964028
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 | |||
|---|---|---|---|---|
| Sys*Stim 228 ME 228 | ME 228 / ME 228 | 00816864020159 | Weight 4.9 lb | On the market |
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- STAODYN EMS+2 by Staodyne, Inc.
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