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510(k) K162470

RT300 FES cycle ergometer by Restorative Therapies, Inc. — Product Code GZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2017
Date Received
September 6, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Neuromuscular, External Functional
Device Class
Class II
Regulation Number
882.5810
Review Panel
NE
Submission Type

Other clearances by Restorative Therapies, Inc.

  • K160614 — Xcite Clinical Station (December 16, 2016)
  • 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 GZI

  • K242704 — Synchrony (20-3000) (June 5, 2025)
  • K243828 — CIONIC NEURAL SLEEVE (NS-200) (May 2, 2025)
  • K240632 — Neuvotion NeuStim NN-01 (November 22, 2024)
  • K233006 — MyndMove, MyndMove 2.0 (June 25, 2024)
  • K230997 — EvoWalk 1.0 System (December 28, 2023)
  • K221823 — Cionic Neural Sleeve NS-100 (July 21, 2022)
  • K213925 — MyoCycle MC-2 (Home / Home + / Pro / Pro +) (April 25, 2022)
  • K212149 — MyndMove 2.0 (March 3, 2022)
  • K213622 — Cionic Neural Sleeve NS-100 (February 14, 2022)
  • K202110 — MStim Drop Model: LGT-233 (November 5, 2021)