The following data is part of a premarket notification filed by Rapid Reboot Recovery Products, Llc with the FDA for Rapid Reboot.
Device ID | K203552 |
510k Number | K203552 |
Device Name: | Rapid Reboot |
Classification | Massager, Powered Inflatable Tube |
Applicant | Rapid Reboot Recovery Products, LLC 1396 W 200 S, Building 2, Unit A Lindon, UT 84042 |
Contact | David Johnson |
Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | IRP |
CFR Regulation Number | 890.5650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2020-12-04 |
Decision Date | 2020-12-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B691SPREN1 | K203552 | 000 |
B691SPREN031 | K203552 | 000 |
B691SPREN021 | K203552 | 000 |
B691SPREN011 | K203552 | 000 |
B691SPGEN031 | K203552 | 000 |
B691SPGEN021 | K203552 | 000 |
B691SPGEN011 | K203552 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RAPID REBOOT 87239705 5232190 Live/Registered |
Rapid Reboot Recovery Products LLC 2016-11-17 |
RAPID REBOOT 87239691 5232189 Live/Registered |
Rapid Reboot Recovery Products LLC 2016-11-16 |