Identity
- Trade Name
- Vasomedical™ AngioNew -VI EECP® Therapy System FDA UDI
- Generic Name
- External counterpulsation system, mobile FDA UDI
- Device Name
- System, AngioNew VI, 220V FDA UDI
- Model / Reference
- Model AngioNew VI FDA UDI
- Description
- System, AngioNew VI, 220V FDA UDI
Identifiers
- Catalog Number
- A12-0004 FDA UDI
- Primary DI / UDI-DI
- 00817980020771 FDA UDI
- 510(k) Number
- K033617 FDA UDI
- FDA Product Code
- DRN FDA UDI
- GMDN Term
- External counterpulsation system, mobile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5225 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: External counterpulsation system, mobile
Vasomedical™ AngioNew -VI EECP® Therapy System by Vasomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External counterpulsation system, mobile.
- RenewTM NCP-5 External Counterpulsation System — S2 EQUIPMENT LLC · Class II
- PSK, Air-bag Type Sequential External Counter-pulsation Device — Chongqing PSK-Health Sci-Tech Development Co., Ltd. · Class II
- RenewTM NCP-5 External Counterpulsation System — RENEW GROUP PRIVATE LIMITED · Class II
- Vasomedical™ AngioNew -VI EECP® Therapy System — VASOMEDICAL, INC. · Class II
Cleared under the same submission
K033617 also covers:
- 3 Lead Integrated ECG Cable (AngioNew® V & VI) — VASOMEDICAL, INC.
- 3 Lead Integrated ECG Cable (Models MC2, TS4 and Lumenair™) — VASOMEDICAL, INC.
- AnKle Strap — VASOMEDICAL, INC.
- Bladder Set, Large — VASOMEDICAL, INC.
- Bladder Set, Medium — VASOMEDICAL, INC.
- Bladder Set, Small — VASOMEDICAL, INC.
- Bladder Set, X-Large (should be used with XL and XXL cuffs) — VASOMEDICAL, INC.
- Bladder Set, X-Small — VASOMEDICAL, INC.
- Calf Cuff, Small, Medium & Large — VASOMEDICAL, INC.
- Calf Cuff, X-Large — VASOMEDICAL, INC.
- Calf Cuff, X-Small — VASOMEDICAL, INC.
- Calf Cuff, XX-Large — VASOMEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vasomedical, Inc.
Sources (1)
- FDA UDI 531634e7-9046-4370-a425-5568a5c942e9 37 fields · synced May 30, 2026