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Mego Afek AC , Ltd.

FDA Regulatory Profile

Mego Afek AC , Ltd. has 0 FDA recalls, 2 inspections, 17 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 6, 2020 · VAI
Latest 510(k)
Apr 14, 2022

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances17Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 6, 2020Afek, IsraelDevicesVoluntary Action Indicated (VAI)3002807566
May 5, 2011Afek, IsraelDevicesVoluntary Action Indicated (VAI)3002807566

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K214053Amputee Garment for use with Lympha Press Optimal PlusApr 14, 2022
K190493Recovery Pump, 737R (RPX)May 15, 2019
K190015Ballancer Gold, 1212Mar 25, 2019
K182003Lympha Press Optimal PlusFeb 27, 2019
K172277Phlebo Press DVT ModelNov 3, 2017
K170658Lympha Press Optimal PlusMay 31, 2017
K163280RP Lite 760RJan 27, 2017
K150269Ballancer 505 System, Model 1201-ACMay 26, 2015
K142772Phlebo Press DVT 603Dec 16, 2014
K140519RECOVERY PUMP 737RJun 16, 2014
K140642PCD 737AJun 10, 2014
K131420PETITE BASIC SYSTEM 701 ELTNov 1, 2013
K121962PRACTICAL COMPRESSION DEVICE (PCD) 901A&901BOct 19, 2012
K112479DSJ MASSAGERDec 7, 2011
K100677LYMPHA PRESS 201MAX, MODEL 201MAXMay 20, 2010
K100521COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUSMay 14, 2010
K082149LYMPHA PRESS OPTIMAL, MODEL# 1201APOct 6, 2008

FDA data resources