Data / Medical devices / United States / Rapid Reboot Recovery Products
Rapid Reboot Recovery Products: FDA-registered device maker in Lindon, UT, United States, 3 510(k) clearances
Rapid Reboot Recovery Products is registered with the FDA (registration 3013787796) in Lindon, UT, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 22, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013787796
- Address
- 1396 W 200 S Building 2 Unit A, Lindon, UT, United States, 84042
- Owner or operator
- Rapid Reboot Recovery Products (10055611)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- August 22, 2017
- Registered through
- 2026
- Brand names listed
- REPLAY Massage Gun, REVAMP Hot/Cold Sleeve, Rapid Reboot, Rapid Reboot Recovery Products
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 22, 2020 | K203552 | Rapid Reboot | IRP | Substantially Equivalent | Rapid Reboot Recovery Products, LLC | accessdata.fda.gov |
| December 14, 2018 | K182668 | Rapid Reboot Compression Therapy System | IRP | Substantially Equivalent | Rapid Reboot Recovery Products, LLC | accessdata.fda.gov |
| February 23, 2017 | K161907 | Pressure Therapy System | IRP | Substantially Equivalent | Xiamen Senyang Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Electric
- All makers of Massager, Powered Inflatable Tube
- All makers of Pack, Hot Or Cold, Reusable
Updated December 22, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.