Identity
- Trade Name
- Compressible Limb Therapy System FDA UDI
- Generic Name
- Sequential venous compression system inflator FDA UDI
- Device Name
- Compressible Limb Therapy System pump with 2leg sleeves(Extra large), 1waist sleeve, 1arm sleeve and 4single hoses. FDA UDI
- Model / Reference
- MK300L FDA UDI
- Description
- Compressible Limb Therapy System pump with 2leg sleeves(Extra large), 1waist sleeve, 1arm sleeve and 4single hoses. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18809315678978 FDA UDI
- 510(k) Number
- K112441 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Sequential venous compression system inflatorPneumatic massager
Compressible Limb Therapy System by Daesung Maref Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pneumatic massager.
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Cleared under the same submission
K112441 also covers:
- Compressible Limb Therapy System — DAESUNG MAREF CO., LTD.
- Compressible Limb Therapy System — DAESUNG MAREF CO., LTD.
- Compressible Limb Therapy System — DAESUNG MAREF CO., LTD.
- Compressible Limb Therapy System(MK300L) — DAESUNG MAREF CO., LTD.
- Compressible Limb Therapy System(MK300L) — DAESUNG MAREF CO., LTD.
- Compressible Limb Therapy System(MK300L) — DAESUNG MAREF CO., LTD.
- Compressible Limb Therapy System(MK300L) — DAESUNG MAREF CO., LTD.
- Compressible Limb Therapy System(MK300L) — DAESUNG MAREF CO., LTD.
- Compressible Limb Therapy System(MK300L) — DAESUNG MAREF CO., LTD.
- Compressible Limb Therapy System(MK300L) — DAESUNG MAREF CO., LTD.
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
- Daesung Maref Co., Ltd.
Sources (1)
- FDA UDI 29df54eb-4cd8-4573-b801-29cf8e3b70ea 34 fields · synced Jun 8, 2026