Public Enquiry - Singapore Medical Device Register (SMDR)
Device Info
Device Name: Restorative Therapies RT300 Functional Electrical Stimulation cycle 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: DE0014180
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 300-SL HomeFA 100052UNITED STATES
2RT-300 SLSAFA 104 581 HomeUNITED STATES
3RT300-SA HomeFA 109064UNITED STATES
4RT 300 UE Upgrade HomeFA 105419 HomeUNITED STATES
5RT 300-SLA HomeFA 102011UNITED STATES
6RT 300 SupineFA 211372 SupineUNITED STATES
7SAGE FES Control SystemSAGE controllerUNITED STATES
8Pulse Oximeter3150UNITED STATES
9Universal Stimulation CablesPP216520UNITED STATES
10Set of Arm and Leg ElectrodesPP100416UNITED STATES
11Set of Arm and Leg ElectrodesPP100015UNITED STATES
12Set of Arm and Leg ElectrodesPP100418UNITED STATES
13UE Ergometer Series 2SA 110368UNITED STATES
14LE Ergometer Series 2SA 110267UNITED STATES
15RT50z wireless stimulatorsSA216128UNITED 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.