| Primary Device ID | B691SPREN021 |
| NIH Device Record Key | b220ebba-ab98-4bc7-88c4-e87b5f17cb0c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rapid Reboot Recovery Products |
| Version Model Number | SP-REN02-1 |
| Company DUNS | 080628101 |
| Company Name | RAPID REBOOT RECOVERY PRODUCTS LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B691SPREN021 [Primary] |
| IRP | Massager, Powered Inflatable Tube |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-20 |
| Device Publish Date | 2021-07-12 |
| B691SPREN1 | REGEN Control Unit |
| B691SPREN031 | RR REGEN Control Unit + Three Attachments |
| B691SPREN021 | RR REGEN Control Unit + Two Attachments |
| B691SPREN011 | RR REGEN Control Unit + Single Attachment |
| B691SPGEN031 | RR GENESIS Control Unit + Three Attachments |
| B691SPGEN021 | RR GENESIS Control Unit + Two Attachments |
| B691SPGEN011 | RR GENESIS Control Unit + Single Attachment |
| B691SPCL031 | RR CLASSIC Control Unit + Three Attachments |
| B691SPCL021 | RR CLASSIC Control Unit + Two Attachments |
| B691SPCL011 | RR CLASSIC Control Unit + Single Attachment |