MEGO afek Agricultural Cooperative Society Ltd

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Sleeve, Limb, Compressible (JOW) (10)

Premarket Exempt

Clear

FL sleeve 3-95 RC-FLS - 07290105872869 Catalog Number : L4133095

Device Description : The FL sleeve 3-95 RC-FLS compression garment fastened around the area to be tre The FL sleeve 3-95 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.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

FL sleeve 4-75 RC-FLS - 07290105872913 Catalog Number : L4134075

Device Description : The FL sleeve 4-75 RC-FLS compression garment fastened around the area to be tre The FL sleeve 4-75 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.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Comfysleeve 2-85 NRC-LEG - 07290105873453 Catalog Number : L41L2285

Device Description : The Comfysleeve 2-85 NRC-LEG compression garment fastened around the area to be The Comfysleeve 2-85 NRC-LEG 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.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Comfysleeve 3-65 NRC-LEG - 07290105873477 Catalog Number : L41L2365

Device Description : The Comfysleeve 3-65 NRC-LEG compression garment fastened around the area to be The Comfysleeve 3-65 NRC-LEG 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.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Comfysleeve 3-75 NRC-LEG - 07290105873484 Catalog Number : L41L2375

Device Description : The Comfysleeve 3-75 NRC-LEG compression garment fastened around the area to be The Comfysleeve 3-75 NRC-LEG 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.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

Comfysleeve 3-85 NRC-LEG - 07290105873491 Catalog Number : L41L2385

Device Description : The Comfysleeve 3-85 NRC-LEG compression garment fastened around the area to be The Comfysleeve 3-85 NRC-LEG 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.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

ComfySleeve 1-75 L-Left NRC-JKT - 07290105873507 Catalog Number : L41LL175L

Device Description : The ComfySleeve 1-75 L-Left NRC-JKT compression garment fastened around the area The ComfySleeve 1-75 L-Left NRC-JKT 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.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

ComfySleeve 1-75 L-Right NRC-JKT - 07290105873514 Catalog Number : L41LL175R

Device Description : The ComfySleeve 1-75 L-Right NRC-JKT ccompression garment fastened around the ar 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.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

ComfySleeve 1-75 M-Left NRC-JKT - 07290105873521 Catalog Number : L41LM175L

Device Description : The ComfySleeve 1-75 M-Left NRC-JKT compression garment fastened around the area The ComfySleeve 1-75 M-Left NRC-JKT 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.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

ComfySleeve 1-75 M-Right NRC-JKT - 07290105873538 Catalog Number : L41LM175R

Device Description : The ComfySleeve 1-75 M-Right NRC-JKT compression garment fastened around the are The ComfySleeve 1-75 M-Right NRC-JKT 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.

Device Class : 2

Duns Number: 514658082

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

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