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PSK, Air-bag Type Sequential External Counter-pulsation Device

Chongqing PSK-Health Sci-Tech Development Co.,Ltd. · Model PECP/TM · UDI-DI 06971379470074

DRN
1
510(k) clearances
58
Adverse events (6 deaths)
1
Recalls
8
Facilities

Recalls

DateFirmReason
2009-04-09Cardiomedics IncorporatedCuff may underinflate, or device may stop working during use. Cardioassist software version 4.3.1 utilized a signal from the plethysmograph that was found not to be sensitive enou

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Data 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.