Public Enquiry - Singapore Medical Device Register (SMDR)
Device Info
Device Name: Restorative Therapies RT200 Functional Electrical Stimulation recumbent elliptical ergometer [Restorative Therapies, Inc.]
Description: Intended for general rehabilitation for :Relaxation of muscle spasms;Prevention or retardation of disuse atrophy; Increasing local blood circulation; Maintaining or increasing range of motion
Medical Specialty Area: Physical Medicine
Medical Device Class: Class B medical device
Device Registration No: DE0014179
Registration Date: 28/10/2013
Change Notification Approval Date: 19/08/2020
Device System Info: [System or Procedure Pack], System
 
Product Owner
1. Restorative Therapies, Inc.  [Restorative Therapies, Inc.] 1434 Fleet Street, Baltimore, MD, 21231, UNITED STATES
Registrant
1. ANDAMAN MEDICAL PTE. LTD.  300 Tampines Avenue 5, #09-02, SINGAPORE 529653
Models
No. Model Name Identifier UDI-DI DM-DI Place of Manufacture
1RT-200 SLSA HomeFA 109136UNITED STATES
2RT-200 SA HomeFA 211762UNITED STATES
3SAGE FES Control SystemSAGE controllerUNITED STATES
4Pulse Oximeter3150UNITED STATES
5Universal Stimulation CablesPP216520UNITED STATES
6Set of Arm and Leg ElectrodesPP100416UNITED STATES
7Set of Arm and Leg ElectrodesPP100015UNITED STATES
8Set of Arm and Leg ElectrodesPP100418UNITED STATES
 
Note: All device listings on the Singapore Medical Device Register (SMDR) are active. Class A medical devices are not registered in the SMDR. To retrieve Class A medical devices, please visit Class A Medical Device Database.