POWERTONE, MODEL PT-11— 510(k) K062439

Name: FDA 510(k) clearance K062439
Creator: U.S. Food and Drug Administration
Published: 2007-01-08

Substantially Equivalent

Johari Digital Healthcare , Ltd.

FDA 510(k) clearance K062439 for POWERTONE, MODEL PT-11, Substantially Equivalent on 2007-01-08. Applicant: Johari Digital Healthcare , Ltd.. Device class: 2.

Clearance details

Applicant: Johari Digital Healthcare , Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2006-08-21
Decision date: 2007-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calabases, CA, US

Download summary PDF View on FDA.gov ↗

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