Identity
- Trade Name
- Lympha Press EUDAMEDFL sleeve 3-75 RC-FLS FDA UDI
- Generic Name
- Multi-chamber venous compression system garment, reusable FDA UDI
- Device Name
- FL Leg Sleeve EUDAMEDThe FL sleeve 3-75 RC-FLS compression garment fastened around the area to be treated. The garment contains overlapping air chambers. These air chambers are filled with air from the console in sequence, applying a compressive massage. Once the entire area has been compressed, the console releases the pressure, and there is a brief pause. Then the process starts over again, and is repeated until the treatment session is complete. FDA UDI
- Model / Reference
- FL EUDAMEDL4133075 EUDAMEDFL 3-75 FDA UDI
- Description
- The FL sleeve 3-75 RC-FLS compression garment fastened around the area to be treated. The garment contains overlapping air chambers. These air chambers are filled with air from the console in sequence, applying a compressive massage. Once the entire area has been compressed, the console releases the pressure, and there is a brief pause. Then the process starts over again, and is repeated until the treatment session is complete. FDA UDI
Identifiers
- Catalog Number
- L4133075 FDA UDI
- Primary DI / UDI-DI
- 07290105876096 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010587FLT2 EUDAMED
- 510(k) Number
- K013331 FDA UDI
- FDA Product Code
- JOW FDA UDI
- EMDN Code
- Z120607 PNEUMATIC COMPRESSION EQUIPMENT EUDAMED
- GMDN Term
- Multi-chamber venous compression system garment, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5800 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Category: Multi-chamber venous compression system garment, reusable
FL sleeve 3-75 RC-FLS by MEGO afek Agricultural Cooperative Society Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K013331 also covers:
- Adult Boot # 1A RC-FLS — MEGO afek Agricultural Cooperative Society Ltd
- Adult boot No. 2A RC-FLS — MEGO afek Agricultural Cooperative Society Ltd
- Bal.Pro Pants-Bot.conn w/o print — MEGO afek Agricultural Cooperative Society Ltd
- Ballancer Pro Jacket — MEGO afek Agricultural Cooperative Society Ltd
- Ballancer Pro Pants (FB) — MEGO afek Agricultural Cooperative Society Ltd
- Ballancer Pro Pants (FS) — MEGO afek Agricultural Cooperative Society Ltd
- Ballancer Pro Pants-Bot.conn — MEGO afek Agricultural Cooperative Society Ltd
- Ballancer Pro Pants-side inlet — MEGO afek Agricultural Cooperative Society Ltd
- Comfysleeve 2-85 NRC-LEG — MEGO afek Agricultural Cooperative Society Ltd
- Comfysleeve 3-65 NRC-LEG — MEGO afek Agricultural Cooperative Society Ltd
- Comfysleeve 3-75 NRC-LEG — MEGO afek Agricultural Cooperative Society Ltd
- Comfysleeve 3-85 NRC-LEG — MEGO afek Agricultural Cooperative Society Ltd
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- MEGO afek Agricultural Cooperative Society Ltd
Sources (2)
- FDA UDI 7a62fb31-d24d-4cfa-8081-ea1fca39b5df 36 fields · synced Oct 6, 2026
- EUDAMED 855baa73-f631-443b-8fd9-e0df0b2e23b0 61 fields · synced Oct 6, 2026