The following data is part of a premarket notification filed by Ortho8 Inc. with the FDA for Circul8 Luxe Dvt Prevention Device.
| Device ID | K211235 |
| 510k Number | K211235 |
| Device Name: | CIRCUL8 Luxe DVT Prevention Device |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Ortho8 Inc. 2217 Plaza Drive Rocklin, CA 95765 |
| Contact | Taylor Nordeen |
| Correspondent | John Beasley MedTech Review, LLC 257 Garnet Garden Street Henderson, NV 89015 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-26 |
| Decision Date | 2021-09-08 |