RT300 FES cycle ergometer
by Restorative Therapies, Inc.
510(k) K162470
RT300 FES cycle ergometer is a Class II device made by Restorative Therapies, Inc., cleared under FDA 510(k) K162470 on 11 Jul 2017, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162470 | Date11 Jul 2017 | StatusActive |
Official records
- FDA 510(k) database K162470
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GZI
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5810
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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