Sys*stim 240
510(k) K113017
Sys*stim 240 is a medical device (FDA Class II; FDA product code IPF, Stimulator, Muscle, Powered) made by Mettler Electronics Corp., cleared under FDA 510(k) K113017 on 26 Jun 2012, 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 | NumberK113017 | Date26 Jun 2012 | StatusActive |
Official records
- FDA 510(k) database K113017
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- Withdrawn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 K113017
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 | |||
|---|---|---|---|---|
| Cluster Applicator 2402 | 2402 / 2402 | 00816864020586 | On the market | |
| Laser Applicator 2401 | 2401 / 2401 | 00816864020579 | On the market | |
| Sys*Stim 240 ME 240 | ME 240 / ME 240 | 00816864020166 | Weight 4.5 lb | On the market |
Similar devices
Other devices filed under FDA product code IPF (Stimulator, Muscle, Powered).
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- MS-159 ELECTRONIC MUSCLE STIMULATOR by Electro Med Supply, Inc.
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- MENTAMOVE by Cole & Associates
- TRIO 300 by ITO CO., LTD.
- MUSCLE STIMULATION SYSTEM by Niveus Medical, Inc.
- STEMPLEX by Rich-Mar Corp.
- BODYFLOW P2CH by PHYSIOMED ELEKTROMEDIZIN AG
- VEINOPLUS NEUROMUSCULAR STIMULATOR by Ad Rem Technology Sarl
- RICH-MAR G1000 EMS by Rich-Mar Corp.