# K160614: Xcite Clinical Station

- Pathway: 510(k) (Traditional)
- Applicant: Restorative Therapies, Inc.
- Decided: Dec 16, 2016 after 288 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K841112 (1984). 8 ancestors in all.
1 later device descends 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)
- K032954: Elpha, Models II 500, II 1000, II 2000, II 3000 and E80, Danmeter A/S (2004) Summary page 4.
- K090750: RT300-SL, Model FA100052; RT300-Slsa, Model FA104581, Restorative Therapies, Inc. (2009) Summary page 4.

## Most influential descendants
- K162470: RT300 FES cycle ergometer (2017), 0 descendants of its own

## Indications for use
The Xcite Clinical Station is intended for general rehabilitation for: 1. Relaxation of muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle re-education 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and 6. Maintaining or increasing range of motion The Xcite system is for prescription use only.

Source page: https://510kreport.com/device/K160614
Methodology: https://510kreport.com/methodology