# K090750: RT300-SL, Model FA100052; RT300-Slsa, Model FA104581

- Pathway: 510(k) (Traditional)
- Applicant: Restorative Therapies, Inc.
- Decided: Aug 5, 2009 after 138 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: 5 generations back to K841112 (1984). 6 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072398: RT300-S and RT300-SP Fes Cycle Ergometer, Restorative Therapies, Inc. (2007) Summary page 1.
- K841112: Tti Rehabilatation Gym Sys, Therapeutic Technologies, Inc. (1984) Summary page 1.
- K073237: Rehastim & Rehamove, Hasomed GmbH (2007) Summary page 1.

## Most influential descendants
- 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 version) are intended for general rehabilitation for: a. Relaxation of muscle spasms b. Prevention or retardation of disuse atrophy c. Increasing local blood circulation d. Maintaining or increasing range of motion The RT300 is for prescription use only. 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.

Source page: https://510kreport.com/device/K090750
Methodology: https://510kreport.com/methodology