Identity
- Trade Name
- Z-Fold ECG Paper, 147 ft. (Models TS3, and TS4 and Lumenair™) FDA UDI
- Generic Name
- External counterpulsation system, stationary FDA UDI
- Device Name
- Z-Fold ECG Paper, 147 ft. (Models TS3, and TS4 and Lumenair™) FDA UDI
- Model / Reference
- Model Lumenair FDA UDI
- Description
- Z-Fold ECG Paper, 147 ft. (Models TS3, and TS4 and Lumenair™) FDA UDI
Identifiers
- Catalog Number
- V93-0003 FDA UDI
- Primary DI / UDI-DI
- 00817980020825 FDA UDI
- 510(k) Number
- K033617 FDA UDI
- FDA Product Code
- DRN FDA UDI
- GMDN Term
- External counterpulsation system, stationary FDA UDI
- Models / Variants
- TS3 FDA UDITS4 FDA UDILumenair™) 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: External counterpulsation system, stationary
Z-Fold ECG Paper, 147 ft. ( (TS3 +2 more) by Vasomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — 3 models — regulatory data on deviCERTS
Similar devices
Also classified as External counterpulsation system, stationary.
- PSK, Air-bag Type Sequential External Counter-pulsation Device — Chongqing PSK-Health Sci-Tech Development Co., Ltd. · Class II
- Omay — Omay(Guangzhou)Med Technologies Co., Ltd. · Class II
- RejuvaHeart — NORTH AMERICAN ECP INC. · Class II
- Bladder Set, Medium — VASOMEDICAL, INC. · Class II
- AnKle Strap — VASOMEDICAL, INC. · Class II
- Bladder Set, Small — VASOMEDICAL, INC. · Class II
- Thigh Cuff, X-Large — VASOMEDICAL, INC. · Class II
- Patient Stop Cable (Model TS4 and Lumenair™) — 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 2cf4ca45-6622-4152-bd20-7b6d5cd959cf 36 fields · synced Jun 1, 2026