The following data is part of a premarket notification filed by Restorative Therapies Inc. with the FDA for Xcite Clinical Station.
| Device ID | K160614 |
| 510k Number | K160614 |
| Device Name: | Xcite Clinical Station |
| Classification | Stimulator, Muscle, Powered |
| Applicant | RESTORATIVE THERAPIES INC. 1434 Fleet Street Baltimore, MD 21231 |
| Contact | Andrew Barriskill |
| Correspondent | Scott Simcox RESTORATIVE THERAPIES INC. 1434 Fleet Street Baltimore, MD 21231 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-03 |
| Decision Date | 2016-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| FA216218 | K160614 | 000 |