The following data is part of a premarket notification filed by Djo, Llc with the FDA for Vectra Neo Clinical Therapy System.
| Device ID | K132284 |
| 510k Number | K132284 |
| Device Name: | VECTRA NEO CLINICAL THERAPY SYSTEM |
| Classification | Stimulator, Muscle, Powered |
| Applicant | DJO, LLC 1430 Decision St Vista, CA 92081 |
| Contact | Maria Pronina |
| Correspondent | Maria Pronina DJO, LLC 1430 Decision St Vista, CA 92081 |
| Product Code | IPF |
| Subsequent Product Code | GZI |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | HCC |
| Subsequent Product Code | ILY |
| Subsequent Product Code | IMG |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-23 |
| Decision Date | 2014-04-10 |
| Summary: | summary |