The following data is part of a premarket notification filed by Djo, Llc with the FDA for Vitalstim(r) Plus Electrotherapy System.
| Device ID | K153224 |
| 510k Number | K153224 |
| Device Name: | VitalStim(R) Plus Electrotherapy System |
| Classification | Stimulator, Muscle, Powered |
| Applicant | DJO, LLC 1430 DECISION STREET Vista, CA 92081 |
| Contact | Natalia Shirina |
| Correspondent | Natalia Shirina DJO, LLC 1430 DECISION STREET Vista, CA 92081 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-06 |
| Decision Date | 2016-02-17 |
| Summary: | summary |