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Device, Counter-Pulsating, External
FDA product code DRN · Class 2 · Cardiovascular
73
Registered devices
58
Adverse events
1
Recalls
34
510(k) clearances
Devices with this code
Vasomedical™Lumenair™ EECP® Therapy System — VASOMEDICAL, INC.Hose Single, (300mm) (AngioNew® VI) — VASOMEDICAL, INC.Thigh Cuff, X-Small — VASOMEDICAL, INC.TwiLoK™ Cuff Side Hose Connector — VASOMEDICAL, INC.Bladder Set, Medium — VASOMEDICAL, INC.Finger Plethysmograph (Models TS3 and TS4) — VASOMEDICAL, INC.3 Lead Integrated ECG Cable (AngioNew® V & VI) — VASOMEDICAL, INC.Vasomedical™ AngioNew -V EECP® Therapy System — VASOMEDICAL, INC.Bladder Set, X-Large (should be used with XL and XXL cuffs) — VASOMEDICAL, INC.Thigh Cuff, XX-Large — VASOMEDICAL, INC.AnKle Strap — VASOMEDICAL, INC.ECP PSK — Chongqing PSK-Health Sci-Tech Development Co.,Ltd.Cuff Set, Small — VASOMEDICAL, INC.Thigh Cuff, Medium — VASOMEDICAL, INC.Treatment Pants, Medium — VASOMEDICAL, INC.PSK, Air-bag Type Sequential External Counter-pulsation Device — Chongqing PSK-Health Sci-Tech Development Co.,Ltd.Vasomedical™ AngioNew -VI EECP® Therapy System — VASOMEDICAL, INC.Cuff Set, XX-Large — VASOMEDICAL, INC.Signa Electrode Gel, 2 oz — VASOMEDICAL, INC.Calf Cuff, Small, Medium & Large — VASOMEDICAL, INC.Z-Fold ECG Paper, 147 ft. (Models TS3, and TS4 and Lumenair™) — VASOMEDICAL, INC.Hose, Set of 6 (AngioNew® VI) — VASOMEDICAL, INC.3 Lead Integrated ECG Cable (Models MC2, TS4 and Lumenair™) — VASOMEDICAL, INC.Patient Stop Cable (AngioNew® V and VI) — VASOMEDICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-04-09 | Cardiomedics Incorporated | Cuff 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 |
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