MEGO AFEK AC Ltd.
Afek Northern, IL
MEGO AFEK AC Ltd. appears in FDA device records in Afek Northern, IL. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for MEGO AFEK AC Ltd. between 2008 and 2022. The busiest year on record is 2014, with 3. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 3 |
| 2015 | 1 |
| 2017 | 3 |
| 2019 | 3 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K214053 | Amputee Garment for use with Lympha Press Optimal Plus | JOW | Substantially Equivalent | |
| K190493 | Recovery Pump, 737R (RPX) | IRP | Substantially Equivalent | |
| K190015 | Ballancer Gold, 1212 | IRP | Substantially Equivalent | |
| K182003 | Lympha Press Optimal Plus | JOW | Substantially Equivalent | |
| K172277 | Phlebo Press DVT Model | JOW | Substantially Equivalent | |
| K170658 | Lympha Press Optimal Plus | JOW | Substantially Equivalent | |
| K163280 | RP Lite 760R | IRP | Substantially Equivalent | |
| K150269 | Ballancer 505 System, Model 1201-AC | IRP | Substantially Equivalent | |
| K142772 | Phlebo Press DVT 603 | JOW | Substantially Equivalent | |
| K140519 | RECOVERY PUMP 737R | IRP | Substantially Equivalent | |
| K140642 | PCD 737A | JOW | Substantially Equivalent | |
| K131420 | PETITE BASIC SYSTEM 701 ELT | JOW | Substantially Equivalent | |
| K121962 | PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B | JOW | Substantially Equivalent | |
| K112479 | DSJ MASSAGER | IRP | Substantially Equivalent | |
| K100677 | LYMPHA PRESS 201MAX, MODEL 201MAX | JOW | Substantially Equivalent | |
| K100521 | COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS | JOW | Substantially Equivalent | |
| K082149 | LYMPHA PRESS OPTIMAL, MODEL# 1201AP | JOW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9611425 | 3002807566 | MEGO AFEK AC Ltd. | Kibbutz Afek, Afek Northern 3004200 IL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain