Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611425

FEI Number

3002807566

Entity Name

MEGO AFEK AC Ltd.

City/State/Country

Afek Northern, IL

Establishment Address

Kibbutz Afek, Afek Northern 3004200, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEGO AFEK Ac Ltd. (Owner Number: 8030066)

Owner / Operator Contact Address

Kibbutz Afek, Post Afek, Afek, IL-NOTA 3004200, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Phlebo Press DVT 603 RecoveryPump 737R RPX 2020 RecoveryAir Pro RecoveryAir Compression Pants Revive M4 Phlebo Press DVT 760D PCD-737A PCD-52 Nano Press 760A-BT Ballancer 505 system model 1201-AC Ballancer Lite COMFYSLEEVE I-75 & LYMPHAPOD SLEEVE Optimal Plus Lympha Press Optimal 1201AD Ballancer Platinum Nano Press 760A RP Lite 760R RecoveryAir Revive M2 LP WAND

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2014-12-17
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2019-05-16
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2017-11-06
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2014-06-16
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2026-02-26
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2016-02-24
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2011-12-18
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2010-12-29
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2019-03-03
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2008-10-28
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2023-06-14
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2013-11-17
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2017-02-05
IRO	Vibrator, Therapeutic	Physical Medicine	Class 1	890.5975	2025-02-13

Official Correspondent

Reuven Yunger

US Agent Details

Deborah Gross Email: dgross@medsolsupplier.com Phone: (732) 8652662

Related Public Records

Same Entity

MEGO AFEK Ac Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04
K242140	Jiale Health Technology Shenzhen Co., Ltd.	Air Compression Leg Massager (K-705)	2025-03-17
K821133	Durham Electric Co.	ELECTRICAL VIBRATING DEVICE	1982-07-09

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3014834638	ZENITH TECHNICAL INNOVATIONS, LLC	Gurnee, IL, US
3009155917	GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611425. Last updated year: 2026. Please use registration number 9611425 when referencing this establishment in official correspondence.