Identity
- Trade Name
- Compressible Limb Therapy System(MK300L) FDA UDI
- Generic Name
- Pneumatic massager FDA UDI
- Device Name
- 6 chamber LEG EXTENSION ZIPPER (Large) FDA UDI
- Model / Reference
- ACg0630 FDA UDI
- Description
- 6 chamber LEG EXTENSION ZIPPER (Large) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809315679077 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
- Not 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
Compressible Limb Therapy System(MK300L) by Daesung Maref Co., Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Daesung Maref Co., Ltd.
Sources (2)
- FDA UDI 91bd5058-f779-4f59-8b84-776ef0d2cfa3 34 fields · synced Jun 9, 2026
- EUDAMED 1 fields · synced May 29, 2026