Rapid Reboot
FDA 510(k) clearance K203552 · decided 2020-12-22
Clearance details
- K-number
- K203552
- Device name
- Rapid Reboot
- Applicant
- Rapid Reboot Recovery Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-12-04
- Decision date
- 2020-12-22
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- IRP
- Device class
- 2
- Regulation number
- 890.5650
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Lindon, UT, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.