Identity
- Trade Name
- Compressible Limb Therapy System(MK300L) FDA UDI
- Generic Name
- Multi-chamber venous compression system garment, reusable FDA UDI
- Device Name
- 6 Chamber leg sleeve (Large) FDA UDI
- Model / Reference
- ACg0610 FDA UDI
- Description
- 6 Chamber leg sleeve (Large) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809315678995 FDA UDI
- 510(k) Number
- K112441 FDA UDI
- FDA Product Code
- IRP FDA UDI
- GMDN Term
- Multi-chamber venous compression system garment, reusable 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multi-chamber venous compression system garment, reusablePneumatic massager
Compressible Limb Therapy System(MK300L) 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 — 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 8d00c494-bf0d-4ef4-9021-7dd523464b17 34 fields · synced May 30, 2026