Medi-Direct TENS Pen— 510(k) K182671

Substantially Equivalent

Jkh USA, LLC

FDA 510(k) clearance K182671 for Medi-Direct TENS Pen, Substantially Equivalent on 2019-09-21. Applicant: Jkh USA, LLC.

Clearance details

Applicant: Jkh USA, LLC
Product code: Code NUH
Advisory panel: Neurology
Date received: 2018-09-26
Decision date: 2019-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Diamond Bar, CA, US

Download summary PDF View on FDA.gov ↗

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