The following data is part of a premarket notification filed by Flowaid Medical Technologies, Corp with the FDA for Fa100 Sccd (sequential Continuous Contraction Device).
| Device ID | K162987 |
| 510k Number | K162987 |
| Device Name: | FA100 SCCD (Sequential Continuous Contraction Device) |
| Classification | Stimulator, Muscle, Powered |
| Applicant | FlowAid Medical Technologies, Corp 44 Wall Street New York, NY 10005 |
| Contact | Jacob Brezel |
| Correspondent | Jacob Brezel FlowAid Medical Technologies, Corp 44 Wall Street New York, NY 10005 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-27 |
| Decision Date | 2017-02-14 |
| Summary: | summary |