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510(k) K160614

Xcite Clinical Station by Restorative Therapies, Inc. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2016
Date Received
March 3, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

Other clearances by Restorative Therapies, Inc.

  • K162470 — RT300 FES cycle ergometer (July 11, 2017)
  • K103370 — RT200 (April 5, 2011)
  • K103366 — RT600 (April 4, 2011)
  • K090750 — RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 (August 5, 2009)
  • K072398 — RT300-S AND RT300-SP FES CYCLE ERGOMETER (November 21, 2007)
  • K071486 — RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053 (September 10, 2007)
  • K071113 — RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053 (July 5, 2007)
  • K060032 — RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053 (March 10, 2006)
  • K050036 — FES CYCLE ERGOMETER, MODEL RT300-S (June 27, 2005)

Other clearances for product code IPF

  • K251083 — Compact II (September 12, 2025)
  • K241433 — EVE Synergy (EVE-20M) (June 4, 2025)
  • K241488 — TrainFES Advance (February 5, 2025)
  • K240348 — Quantum Mitohormesis (QMT) (M2101) (December 19, 2024)
  • K240992 — eMVFit (MVF-10M) (October 10, 2024)
  • K240234 — BTL-899MS (August 17, 2024)
  • K233098 — MYOTouch Muscle Stimulator (August 2, 2024)
  • K232786 — Stimulation System (PA series, PR series, S series and Q series) (May 16, 2024)
  • K233926 — accufit (March 21, 2024)
  • K233485 — M-Wave (January 26, 2024)