Identity
- Trade Name
- EXTENSION ZIPPER FDA UDI
- Generic Name
- Sequential venous compression system inflator FDA UDI
- Device Name
- EXTENSION ZIPPER for POWER Q1000 PREMIUM FDA UDI
- Model / Reference
- POWER-Q1000PREMIUM FDA UDI
- Description
- EXTENSION ZIPPER for POWER Q1000 PREMIUM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809277423213 FDA UDI
- 510(k) Number
- K113275 FDA UDI
- FDA Product Code
- IRP FDA UDI
- GMDN Term
- Sequential venous compression system inflator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5650 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: Sequential venous compression system inflator
Extension Zipper by Wonjin Mulsan Co.ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- TRIPLE PLAY — Compression Solutions, LLC · Class II
Cleared under the same submission
K113275 also covers:
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
- Wonjin Mulsan Co.ltd
Sources (1)
- FDA UDI 1bb3161b-b7b9-4f86-b9eb-73469ea22bcb 34 fields · synced May 30, 2026