Public Enquiry - Singapore Medical Device Register (SMDR)
Device Info
Device Name: Restorative Therapies Xcite Clinical Station [Restorative Therapies, Inc.]
Description: Xcite is intended to be used for the following: 1. Muscle re-education 2. Relaxation of muscle spasms 3. Prevention or retardation of disuse atrophy 4. Maintaining or increasing range of motion 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Medical Specialty Area: Physical Medicine
Medical Device Class: Class B medical device
Device Registration No: DE0504604
Registration Date: 17/06/2020
Change Notification Approval Date: 20/09/2021
 
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
1Xcite Clinical StationFA216218+M720FA2162180UNITED STATES
2Xcite StimulatorSA216201N/AUNITED STATES
3Xcite Cart SA110267N/AUNITED STATES
4XciteV2 StimulatorSA220070N/AUNITED STATES
5XciteV2 CartSA220063N/AUNITED STATES
6XciteV2 Smart BatteryPP219918N/AUNITED STATES
7Stimulation CablePP217417N/AUNITED STATES
8Power AdaptorPP216206N/ATAIWAN
9PALS Neurostimulation electrodesPP10728900856817005413UNITED STATES
10PALS Neurostimulation electrodesPP10273800856817005642UNITED STATES
11PALS Neurostimulation electrodesPP10042100856817005635UNITED STATES
12PALS Neurostimulation electrodesPP10042000856817005536UNITED STATES
13PALS Neurostimulation electrodesPP10041900856817005505UNITED STATES
14PALS Neurostimulation electrodesPP10041800856817005468UNITED STATES
15PALS Neurostimulation electrodesPP10001500856817005475UNITED STATES
16PALS Neurostimulation electrodesPP22027600851913006326UNITED 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.