The following data is part of a premarket notification filed by Rapid Reboot Recovery Products, Llc with the FDA for Rapid Reboot Compression Therapy System.
| Device ID | K182668 |
| 510k Number | K182668 |
| Device Name: | Rapid Reboot Compression Therapy System |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Rapid Reboot Recovery Products, LLC 1396 W 200 S Bldg 2A Lindon, UT 84042 |
| Contact | David Johnson |
| Correspondent | John F Gillespy FDA Consulting, LLC 1100 Del Lago Cir #104 Palm Beach Gardens, FL 33410 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-25 |
| Decision Date | 2018-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B691SPCL031 | K182668 | 000 |
| B691SPCL021 | K182668 | 000 |
| B691SPCL011 | K182668 | 000 |