Fes Cycle Ergometer, Model RT300-S
by Restorative Therapies, Inc.
510(k) K050036
Fes Cycle Ergometer, Model RT300-S is a Class II device made by Restorative Therapies, Inc., cleared under FDA 510(k) K050036 on 27 Jun 2005, 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 | NumberK050036 | Date27 Jun 2005 | StatusActive |
Official records
- FDA 510(k) database K050036
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- Withdrawn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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