Ballancer Platinum (1222)— 510(k) K230385

Substantially Equivalent

Mego Afek

FDA 510(k) clearance K230385 for Ballancer Platinum (1222), Substantially Equivalent on 2023-04-04. Applicant: Mego Afek. Device class: 2.

Clearance details

Applicant: Mego Afek
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2023-02-14
Decision date: 2023-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kibbuts Afek, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code IRP

K260944 — ManaCold Compression System2026-08-12
K260529 — Air Compression Massager (HY-1165)2026-07-27
K260948 — Air Compression Massager (EP30B001 I)2026-07-24
K253919 — Cryo And Thermo Therapy System2026-06-10
K252396 — Cryo Sport 2.0 (AVA 501)2026-05-29

More clearances from Mego Afek

K072372 — PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE2007-11-21
K060220 — PBS MODEL 701A COMPRESSION THERAPY DEVICE2006-02-09
K013331 — LYMPHA PRESS PLUS DEVICE2001-11-30
K810338 — LYMPHA PRESS1981-10-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.