# K071113: RT300-S, Model FA100052, RT300-SP (Pediatric Version), Model FA100053

- Pathway: 510(k) (Traditional)
- Applicant: Restorative Therapies, Inc.
- Decided: Jul 5, 2007 after 76 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: 2 generations back to K841112 (1984). 2 ancestors in all.
7 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)
- K060032: RT300-S, Model FA100052; RT300-SP, Model FA100053, Restorative Therapies, Inc. (2006) Summary page 1.

## Most influential descendants
- K071486: RT300-S, RT300-SP (Pediatric Version), Model FA100052, FA100053 (2007), 6 descendants of its own
- K072398: RT300-S and RT300-SP Fes Cycle Ergometer (2007), 5 descendants of its own
- 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

## Indications for use
The RT300-S (adult version) and RT300-SP (pediatric version) 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-SP (pediatric version), is intended for population ages 4 to 12 years.

Source page: https://510kreport.com/device/K071113
Methodology: https://510kreport.com/methodology