Xcite Clinical Station
by Restorative Therapies, Inc.
510(k) K160614
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160614 | Date16 Dec 2016 | StatusActive |
Official records
- FDA 510(k) database K160614
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IPF
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Xcite Clinical Station is an integrated Functional Electrical Stimulation (FES) therapy system designed for muscle re-education, functional movement, and independence for patients with neurological weakness or paralysis. It features 40+ pre-programmed, task-specific activities that support rehabilitation in clinical settings.
This device is supplied as a clinical station and is intended for use in medical environments. The Xcite Clinical Station is authorized under FDA 510(k) clearance with product code IPF and was cleared on December 16, 2016. It is manufactured by Restorative Therapies, Inc. in Baltimore, Maryland.
From the manufacturer
Xcite2 is an integrated FES clinical station with 40+ pre-programmed, task-specific activities that support muscle re-education, functional movement, and independence for patients with neurological weakness or paralysis.
Partner with Restorative Therapies to revolutionize mobility solutions through integrated FES technology. Learn how collaboration can transform patient outcomes.
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