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ManaMed Transducer Fixation Strap
Manamed, Inc. · Model MTWTSTRAP · UDI-DI 00810113682754
10
510(k) clearances
60
Adverse events
3
Recalls
25
Facilities
Description
The ManaSport+ provides non-invasive therapy of low-intensity pulsed ultrasound for the treatment of selected sub-chronic and chronic medical conditions such as soft tissue injuries, shortened tendons due to past injuries and scar tissues, relief of pain, muscle spasms and joint contractures. ManaSport+ transmits a low-intensity ultrasound signal to the patient’s treatment site through ultrasound gel. The patient will experience little or no sensation while in ultrasound mode. The weighted strap holds the transducer where treatment is desired.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-02-28 | Chattanooga Corp Inc | Device may fail to administer therapy during use. |
| 2008-02-28 | Chattanooga Corp Inc | Device may fail to administer therapy during use. |
| 2005-01-05 | Sybaritic, Inc | Device is performing functions that are not cleared in the 510(k). |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.