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ReDS Wearable System
SENSIBLE MEDICAL INNOVATIONS LTD · Model V2.6 · UDI-DI 07290110070038
DSB
Prescription
1
510(k) clearances
6
Adverse events
2
Recalls
68
Facilities
Description
Clinicl Kit including magnet, pins and caps for vest adjustment locking, to enable shipment of extra parts to the clinic (Related to ReDS Wearable System).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-09-02 | Baxter Healthcare Corporation | Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards. |
| 2015-12-01 | Partners In Medicine Llc | Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects - mainly in tall and slim persons (overestimation |
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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.