Data / Medical devices / Israel / MEGO AFEK AC Ltd.
MEGO AFEK AC Ltd.: FDA-registered device maker in Afek Northern, Israel, 18 510(k) clearances
MEGO AFEK AC Ltd. is registered with the FDA (registration 9611425) in Afek Northern, Israel. It lists 3 device types. The FDA files 18 510(k) clearances under its listings, the newest dated February 24, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9611425
- FEI number
- 3002807566
- Address
- Kibbutz Afek, Afek Northern, Israel, 3004200
- Owner or operator
- MEGO AFEK Ac Ltd. (8030066)
- Roles
- Manufacturer
- First device listed
- January 18, 1981
- Registered through
- 2026
- Brand names listed
- Adjustable amputee garment, Ballancer 505 system model 1201-AC, Ballancer Gold, Ballancer Lite, Ballancer Platinum, COMFYSLEEVE I-75 & LYMPHAPOD SLEEVE, LP WAND, Lympha Press and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Manufacturer | accessdata.fda.gov |
| Vibrator, Therapeutic | IRO | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 24, 2026 | K254267 | NanoPress 760A-BT (760A-BT) | JOW | Substantially Equivalent | Mego Afek , Ltd. | accessdata.fda.gov |
| April 4, 2023 | K230385 | Ballancer Platinum (1222) | IRP | Substantially Equivalent | Mego Afek | accessdata.fda.gov |
| April 14, 2022 | K214053 | Amputee Garment for use with Lympha Press Optimal Plus | JOW | Substantially Equivalent | Mego Afek AC , Ltd. | accessdata.fda.gov |
| May 15, 2019 | K190493 | Recovery Pump, 737R (RPX) | IRP | Substantially Equivalent | Mego Afek AC , Ltd. | accessdata.fda.gov |
| March 25, 2019 | K190015 | Ballancer Gold, 1212 | IRP | Substantially Equivalent | Mego Afek AC , Ltd. | accessdata.fda.gov |
| February 27, 2019 | K182003 | Lympha Press Optimal Plus | JOW | Substantially Equivalent | Mego Afek AC , Ltd. | accessdata.fda.gov |
| November 3, 2017 | K172277 | Phlebo Press DVT Model | JOW | Substantially Equivalent | Mego Afek AC , Ltd. | accessdata.fda.gov |
| May 31, 2017 | K170658 | Lympha Press Optimal Plus | JOW | Substantially Equivalent | Mego Afek AC , Ltd. | accessdata.fda.gov |
| January 27, 2017 | K163280 | RP Lite 760R | IRP | Substantially Equivalent | Mego Afek AC , Ltd. | accessdata.fda.gov |
| May 26, 2015 | K150269 | Ballancer 505 System, Model 1201-AC | IRP | Substantially Equivalent | Mego Afek AC , Ltd. | accessdata.fda.gov |
| December 16, 2014 | K142772 | Phlebo Press DVT 603 | JOW | Substantially Equivalent | Mego Afek AC , Ltd. | accessdata.fda.gov |
| June 10, 2014 | K140642 | PCD 737A | JOW | Substantially Equivalent | Mego Afek AC , Ltd. | accessdata.fda.gov |
| November 1, 2013 | K131420 | PETITE BASIC SYSTEM 701 ELT | JOW | Substantially Equivalent | Mego Afek AC , Ltd. | accessdata.fda.gov |
| October 19, 2012 | K121962 | PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B | JOW | Substantially Equivalent | Mego Afek AC , Ltd. | accessdata.fda.gov |
| December 7, 2011 | K112479 | DSJ MASSAGER | IRP | Substantially Equivalent | Mego Afek AC , Ltd. | accessdata.fda.gov |
| May 14, 2010 | K100521 | COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS | JOW | Substantially Equivalent | Mego Afek AC , Ltd. | accessdata.fda.gov |
| October 6, 2008 | K082149 | LYMPHA PRESS OPTIMAL, MODEL# 1201AP | JOW | Substantially Equivalent | Mego Afek AC , Ltd. | accessdata.fda.gov |
| February 9, 2006 | K060220 | PBS MODEL 701A COMPRESSION THERAPY DEVICE | JOW | Substantially Equivalent | Mego Afek | accessdata.fda.gov |
Compare with other makers
- All makers of Sleeve, Limb, Compressible
- All makers of Massager, Powered Inflatable Tube
- All makers of Vibrator, Therapeutic
Updated February 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.