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Smart Check Cushion Monitoring Device
Roho, Inc. · Model SMARTCHECK-01 · UDI-DI 00613732087746
10
510(k) clearances
2
Adverse events
1
Recalls
40
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-07-20 | Xsensor Technology Corporation | The plastic enclosures for the X3 Display and X3 PRO Pressure Mapping System has a UL94 HB flammability rating while the medical equipment specification UL 60601-1 requires V-2 rat |
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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.