Identity
- Trade Name
- ComfySleeve 1-75 L-Right NRC-JKT FDA UDI
- Generic Name
- Multi-chamber venous compression system garment, reusable FDA UDI
- Device Name
- The ComfySleeve 1-75 L-Right NRC-JKT ccompression 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
- Comfy 1-75 L Right FDA UDI
- Description
- The ComfySleeve 1-75 L-Right NRC-JKT ccompression 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
- L41LL175R FDA UDI
- Primary DI / UDI-DI
- 07290105873514 FDA UDI
- 510(k) Number
- K100521 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Multi-chamber venous compression system garment, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5800 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
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
ComfySleeve 1-75 L-Right NRC-JKT by MEGO afek Agricultural Cooperative Society Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-chamber venous compression system garment, reusable.
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- Flexitouch — TACTILE SYSTEMS TECHNOLOGY INC · Class II
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- Bio Compression Systems 4 Chamber Leg Sleeve Medium Narrow - Black — BIO COMPRESSION SYSTEMS, INC. · Class II
Cleared under the same submission
K100521 also covers:
- ComfySleeve 1-75 L-Left NRC-JKT — MEGO afek Agricultural Cooperative Society Ltd
- ComfySleeve 1-75 M-Left NRC-JKT — MEGO afek Agricultural Cooperative Society Ltd
- ComfySleeve 1-75 S-Left NRC-JKT — MEGO afek Agricultural Cooperative Society Ltd
- LymphaPod - Left Hose NRC-POD — MEGO afek Agricultural Cooperative Society Ltd
- LymphaPod - Right Hose NRC-POD — MEGO afek Agricultural Cooperative Society Ltd
- LymphaPod L.Hose, closed NRC-POD — MEGO afek Agricultural Cooperative Society Ltd
- LymphaPod R.Hose, closed NRC-POD — MEGO afek Agricultural Cooperative Society Ltd
- Right Arm and Torso NRC-JKT — MEGO afek Agricultural Cooperative Society 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
- MEGO afek Agricultural Cooperative Society Ltd
Sources (1)
- FDA UDI 14917f1e-0544-471e-a5f1-63cfbbdf5d7e 36 fields · synced May 30, 2026