510(k) K230385— Ballancer Platinum (1222)

Substantially Equivalent

Mego Afek

Clearance details

Applicant: Mego Afek
Product code: Code IRP
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 ↗

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