# K162470: RT300 FES cycle ergometer

- Pathway: 510(k) (Traditional)
- Applicant: Restorative Therapies, Inc.
- Decided: Jul 11, 2017 after 308 days
- Product code: GZI (Stimulator, Neuromuscular, External Functional)
- Device class: 2
- Regulation: 21 CFR 882.5810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K841112 (1984). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090750: RT300-SL, Model FA100052; RT300-Slsa, Model FA104581, Restorative Therapies, Inc. (2009) Summary page 4.
- K160614: Xcite Clinical Station, Restorative Therapies, Inc. (2016). Cleared while this submission was under review Summary page 4.

## Indications for use
The RT300 is intended for general rehabilitation for: 1. Relaxation of muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Maintaining or increasing range of motion 5. Muscle re-education The RT300 pediatric version is intended for population ages 4 to 12 years. The RT300 is intended for use with a surface electrical stimulation garment for population ages 12 and above. The RT300 is for prescription use only.

Source page: https://510kreport.com/device/K162470
Methodology: https://510kreport.com/methodology