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 (* Cancelled wef 04/11/2022)
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
1	RT600 Home System	FA 211509			UNITED STATES
2	SAGE FES Control System	SAGE controller			UNITED STATES
3	Pulse Oximeter	3150			UNITED STATES
4	Universal Stimulation Cables	PP216520			UNITED STATES
5	Set of Arm and Leg Electrodes	PP100416			UNITED STATES
6	Set of Arm and Leg Electrodes	PP100015			UNITED STATES
7	Set of Arm and Leg Electrodes	PP100418			UNITED STATES
8	RT 600 Hoist Assembly	FA 213565			UNITED STATES
9	Harness Adult	PP213567			UNITED STATES
10	Harness Paediatric	PP 213568			UNITED STATES

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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.