Cleared Traditional

Modpod

K150695 · Hollywog, LLC · Physical Medicine
Aug 2015
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K150695 is an FDA 510(k) clearance for the Modpod, a Equipment, Traction, Powered (Class II — Special Controls, product code ITH), submitted by Hollywog, LLC (Chattanooga, US). The FDA issued a Cleared decision on August 13, 2015, 148 days after receiving the submission on March 18, 2015. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5900.

Submission Details

510(k) Number K150695 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2015
Decision Date August 13, 2015
Days to Decision 148 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code ITH — Equipment, Traction, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5900

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