# K072398: RT300-S and RT300-SP Fes Cycle Ergometer

- Pathway: 510(k) (Traditional)
- Applicant: Restorative Therapies, Inc.
- Decided: Nov 21, 2007 after 86 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: 4 generations back to K841112 (1984). 4 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071486: RT300-S, RT300-SP (Pediatric Version), Model FA100052, FA100053, Restorative Therapies, Inc. (2007). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K090750: RT300-SL, Model FA100052; RT300-Slsa, Model FA104581 (2009), 4 descendants of its own
- K160614: Xcite Clinical Station (2016), 1 descendant of its own
- K162470: RT300 FES cycle ergometer (2017), 0 descendants of its own
- K103370: RT200 (2011), 0 descendants of its own
- K103366: RT600 (2011), 0 descendants of its own

## Indications for use
The RT300 adult and pediatric versions are 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 The RT300 pediatric version is intended for population ages 4 to 12 years.

Source page: https://510kreport.com/device/K072398
Methodology: https://510kreport.com/methodology