Identity
- Trade Name
- WONJIN FDA UDI
- Generic Name
- Sequential venous compression system inflator FDA UDI
- Device Name
- Sequential venous compressiion system pump, a power inflatable tube massager FDA UDI
- Model / Reference
- POWER-Q2300 FDA UDI
- Description
- Sequential venous compressiion system pump, a power inflatable tube massager FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809277423466 FDA UDI
- 510(k) Number
- K100656 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sequential venous compression system inflator
Wonjin by Wonjin Mulsan Co.ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sequential venous compression system inflator.
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- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Bio Compression Systems Sequential Circulator Model SC-3008-IS — BIO COMPRESSION SYSTEMS, INC. · Class II
- Air Relax Classic Model AR-2.0 Leg Recovery System - Size 2 — Maxstar Industrial Co., Ltd. · Class II
- TRIPLE PLAY — Compression Solutions, LLC · Class II
Cleared under the same submission
K100656 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 54579ee2-58cf-43f3-bc6c-7f34f3bd3502 34 fields · synced May 29, 2026