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Compressible Limb Therapy System(Lympha-Flow(LF400))
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Compressible Limb Therapy System(Lympha-Flow(LF400)) FDA UDI
- Generic Name
- Pneumatic massager FDA UDI
- Device Name
- 4 Chamber Overlapping Half-leg (Medium) sleeve with Hose FDA UDI
- Model / Reference
- ACg0470 FDA UDI
- Description
- 4 Chamber Overlapping Half-leg (Medium) sleeve with Hose FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809315678308 FDA UDI
- 510(k) Number
- K150033 FDA UDI
- FDA Product Code
- IRP FDA UDI
- GMDN Term
- Pneumatic massager 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: Pneumatic massager
Compressible Limb Therapy System(Lympha-Flow(LF400)) by Daesung Maref Co., Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Pneumatic massager.
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Cleared under the same submission
K150033 also covers:
- 4 chamber extension zipper — DAESUNG MAREF CO., LTD.
- 4 chamber extension zipper — DAESUNG MAREF CO., LTD.
- 4 chamber extension zipper — DAESUNG MAREF CO., LTD.
- 4 chamber extension zipper — DAESUNG MAREF CO., LTD.
- 4 chamber sleeve — DAESUNG MAREF CO., LTD.
- 4 chamber sleeve — DAESUNG MAREF CO., LTD.
- 4 chamber sleeve — DAESUNG MAREF CO., LTD.
- 4 chamber sleeve — DAESUNG MAREF CO., LTD.
- 4 chamber sleeve — DAESUNG MAREF CO., LTD.
- 4 chamber sleeve — DAESUNG MAREF CO., LTD.
- 4 chamber sleeve — DAESUNG MAREF CO., LTD.
- 4 chamber sleeve — DAESUNG MAREF CO., LTD.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Daesung Maref Co., Ltd.
Sources (2)
- FDA UDI df731eef-8bc2-427d-bf3d-ae4c4e0c3da4 34 fields · synced Jun 1, 2026
- EUDAMED 1 fields · synced May 25, 2026