The following data is part of a premarket notification filed by Katalyst Inc. with the FDA for Katalyst Mark 1 Muscle Stimulation System Model 2.
| Device ID | K181199 |
| 510k Number | K181199 |
| Device Name: | Katalyst Mark 1 Muscle Stimulation System Model 2 |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Katalyst Inc. 316 Occidental Ave. South Suite B300 Seattle, WA 98104 |
| Contact | Bjoern Woltermann |
| Correspondent | Bjoern Woltermann Katalyst Inc. 316 Occidental Ave. South Suite B300 Seattle, WA 98104 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-07 |
| Decision Date | 2018-09-20 |
| Summary: | summary |