| Device Name: |
Restorative Therapies Xcite Clinical Station [Restorative Therapies] |
| 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: |
31/05/2023
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| 1. Restorative Therapies
[Restorative Therapies] 8098 Sandpiper Circle Suite M, Nottingham, MD 21236, UNITED STATES
|
| No. |
Model Name |
Identifier |
UDI-DI |
DM-DI |
Place of Manufacture |
| 1 | Xcite Clinical Station | FA216218 | +M720FA2162180 | | UNITED STATES | | 2 | Xcite Stimulator | SA216201 | N/A | | UNITED STATES | | 3 | Xcite Cart | SA110267 | N/A | | UNITED STATES | | 4 | XciteV2 Stimulator | SA220070 | N/A | | UNITED STATES | | 5 | XciteV2 Cart | SA220063 | N/A | | UNITED STATES | | 6 | XciteV2 Smart Battery | PP219918 | N/A | | UNITED STATES | | 7 | Stimulation Cable | PP217417 | N/A | | UNITED STATES | | 8 | Power Adaptor | PP216206 | N/A | | TAIWAN | | 9 | PALS Neurostimulation electrodes | PP107289 | 00856817005413 | | UNITED STATES | | 10 | PALS Neurostimulation electrodes | PP102738 | 00856817005642 | | UNITED STATES | | 11 | PALS Neurostimulation electrodes | PP100421 | 00856817005635 | | UNITED STATES | | 12 | PALS Neurostimulation electrodes | PP100420 | 00856817005536 | | UNITED STATES | | 13 | PALS Neurostimulation electrodes | PP100419 | 00856817005505 | | UNITED STATES | | 14 | PALS Neurostimulation electrodes | PP100418 | 00856817005468 | | UNITED STATES | | 15 | PALS Neurostimulation electrodes | PP100015 | 00856817005475 | | UNITED STATES | | 16 | PALS Neurostimulation electrodes | PP220276 | 00851913006326 | | 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.
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