The following data is part of a premarket notification filed by Xtreem Pulse, Llc with the FDA for Pure Flow External Counter-pulsation Device.
| Device ID | K173483 |
| 510k Number | K173483 |
| Device Name: | Pure Flow External Counter-Pulsation Device |
| Classification | Device, Counter-pulsating, External |
| Applicant | Xtreem Pulse, LLC 353 W 29 St., Suite 3 New York, NY 10001 |
| Contact | Andrew Barile |
| Correspondent | Rhonda Alexander IUVO Consulting, LLC 1820 Perla Drive Virginia Beach, VA 23456 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-13 |
| Decision Date | 2018-05-30 |
| Summary: | summary |