The following data is part of a premarket notification filed by Mettler Electronics Corp. with the FDA for Sys Stim 206(model-me 206) Muscle Stimulator.
| Device ID | K850013 |
| 510k Number | K850013 |
| Device Name: | SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR |
| Classification | Stimulator, Muscle, Powered |
| Applicant | METTLER ELECTRONICS CORP. 1333 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
| Contact | Rob Fleming |
| Correspondent | Rob Fleming METTLER ELECTRONICS CORP. 1333 SOUTH CLAUDINA ST. Anaheim, CA 92805 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-02 |
| Decision Date | 1985-04-08 |