Public Enquiry - Singapore Medical Device Register (SMDR)
Device Info
Device Name: Restorative Therapies RT600 FES Stepper 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: DE0014178
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
1RT600 Home SystemFA 211509UNITED STATES
2SAGE FES Control SystemSAGE controllerUNITED STATES
3Pulse Oximeter3150UNITED STATES
4Universal Stimulation CablesPP216520UNITED STATES
5Set of Arm and Leg ElectrodesPP100416UNITED STATES
6Set of Arm and Leg ElectrodesPP100015UNITED STATES
7Set of Arm and Leg ElectrodesPP100418UNITED STATES
8RT 600 Hoist AssemblyFA 213565UNITED STATES
9Harness AdultPP213567UNITED STATES
10Harness PaediatricPP 213568UNITED 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.