Xcite Clinical Station
FDA 510(k) K160614 · Restorative Therapies, Inc.
510(k) numberK160614
Submission
- Device name
- Xcite Clinical Station
- Applicant
- Restorative Therapies, Inc.
Baltimore, MD, US - Received
- March 3, 2016
- Decision date
- December 16, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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More from Sunmed, LLC
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| K162470 | RT300 FES cycle ergometerGZI · Traditional | 07/11/2017SE |
| K103370 | RT200GZI · Traditional | 04/05/2011SE |
| K103366 | RT600GZI · Traditional | 04/04/2011SE |
| K090750 | RT300-SL, Model FA100052; RT300-SLSA, Model FA104581GZI · Traditional | 08/05/2009SE |
| K072398 | RT300-S and RT300-SP Fes Cycle ErgometerGZI · Traditional | 11/21/2007SE |
| K071486 | RT300-S, RT300-SP (Pediatric Version), Model FA100052, FA100053GZI · Special | 09/10/2007SE |
| K071113 | RT300-S, Model FA100052, RT300-SP (Pediatric Version), Model FA100053GZI · Traditional | 07/05/2007SE |
| K060032 | RT300-S, Model FA100052; RT300-SP, Model FA100053GZI · Special | 03/10/2006SE |
| K050036 | Fes Cycle Ergometer, Model RT300-SGZI · Abbreviated | 06/27/2005SE |
Questions and answers
When was Xcite Clinical Station cleared by the FDA?
Xcite Clinical Station (K160614) received a 510(k) decision of Substantially Equivalent on December 16, 2016, 288 days after the submission was received.
What is the product code of K160614?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.