Medical Device Manufacturer · IL , Kfar Saba

Mego Afek AC , Ltd. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 2008
17
Total
17
Cleared
0
Denied

Mego Afek AC , Ltd. has 17 FDA 510(k) cleared medical devices. Based in Kfar Saba, IL.

Last cleared in 2022. Active since 2008. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Mego Afek AC , Ltd. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Ilan Sharon MD Consultant as regulatory consultant.

FDA 510(k) Regulatory Record - Mego Afek AC , Ltd.

17 devices
1-17 of 17
Cleared Apr 14, 2022
Amputee Garment for use with Lympha Press Optimal Plus
K214053 · JOW
Cardiovascular · 108d
Cleared May 15, 2019
Recovery Pump, 737R (RPX)
K190493 · IRP
Physical Medicine · 76d
Cleared Mar 25, 2019
Ballancer Gold, 1212
K190015 · IRP
Physical Medicine · 81d
Cleared Feb 27, 2019
Lympha Press Optimal Plus
K182003 · JOW
Cardiovascular · 216d
Cleared Nov 03, 2017
Phlebo Press DVT Model
K172277 · JOW
Cardiovascular · 98d
Cleared May 31, 2017
Lympha Press Optimal Plus
K170658 · JOW
Cardiovascular · 89d
Cleared Jan 27, 2017
RP Lite 760R
K163280 · IRP
Physical Medicine · 67d
Cleared May 26, 2015
Ballancer 505 System, Model 1201-AC
K150269 · IRP
Physical Medicine · 111d
Cleared Dec 16, 2014
Phlebo Press DVT 603
K142772 · JOW
Cardiovascular · 82d
Cleared Jun 16, 2014
RECOVERY PUMP 737R
K140519 · IRP
Physical Medicine · 108d
Cleared Jun 10, 2014
PCD 737A
K140642 · JOW
Cardiovascular · 90d
Cleared Nov 01, 2013
PETITE BASIC SYSTEM 701 ELT
K131420 · JOW
Cardiovascular · 169d
Cleared Oct 19, 2012
PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B
K121962 · JOW
Cardiovascular · 106d
Cleared Dec 07, 2011
DSJ MASSAGER
K112479 · IRP
Physical Medicine · 100d
Cleared May 20, 2010
LYMPHA PRESS 201MAX, MODEL 201MAX
K100677 · JOW
Cardiovascular · 71d
Cleared May 14, 2010
COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS
K100521 · JOW
Cardiovascular · 80d
Cleared Oct 06, 2008
LYMPHA PRESS OPTIMAL, MODEL# 1201AP
K082149 · JOW
Cardiovascular · 68d
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