# Mego Afek AC, Ltd.

- Location (FDA's records): Kibbutz Afek, IL
- FDA decisions: 17 (2008–2022): 17 510(k) clearances
- Product codes: JOW (11), IRP (6)
- 510(k) review time since 2016: median 89 days, against 88 for FDA's reviews in the same codes and years (5 of 7 faster)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 13 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mego Afek: 3 (https://510kreport.com/company/mego-afek)

## Firms that cite its devices most
- Slk Medical GmbH: 2 (https://510kreport.com/company/slk-medical)
- Biotab, LLC: 1 (https://510kreport.com/company/biotab)
- Tactile Systems Technology, Inc.: 1 (https://510kreport.com/company/tactile-systems-technology)
- Tactile Systems Technology, Inc. (Dba Tactile Medical): 1 (https://510kreport.com/company/tactile-systems-technology-dba-tactile-medical)
- Devon Medical, Inc.: 1 (https://510kreport.com/company/devon-medical)
- Theragun, Inc.: 1 (https://510kreport.com/company/theragun)
- Bio Compression Systems, Inc.: 1 (https://510kreport.com/company/bio-compression-systems)
- Hanuri Distribution, Inc.: 1 (https://510kreport.com/company/hanuri-distribution)

## Its most-cited devices
- K082149: Lympha Press Optimal, Model# 1201AP (2008), cited by 3
- K112479: DSJ Massager (2011), cited by 3
- K100677: Lympha Press 201MAX, Model 201MAX (2010), cited by 2
- K182003: Lympha Press Optimal Plus (2019), cited by 2
- K131420: Petite Basic System 701 Elt (2013), cited by 1
- K150269: Ballancer 505 System, Model 1201-AC (2015), cited by 1

## Recent decisions
- K214053: Amputee Garment for use with Lympha Press Optimal Plus (Apr 14, 2022)
- K190493: Recovery Pump, 737R (RPX) (May 15, 2019)
- K190015: Ballancer Gold, 1212 (Mar 25, 2019)
- K182003: Lympha Press Optimal Plus (Feb 27, 2019)
- K172277: Phlebo Press DVT Model (Nov 3, 2017)
- K170658: Lympha Press Optimal Plus (May 31, 2017)
- K163280: RP Lite 760R (Jan 27, 2017)
- K150269: Ballancer 505 System, Model 1201-AC (May 26, 2015)

Source page: https://510kreport.com/company/mego-afek-ac