Cleared Traditional

LO-BAK TRAX

K110858 · Roland F Berthiaume, DC · Neurology

Aug 2011

Decision

127d

Days

Class 1

Risk

About This 510(k) Submission

K110858 is an FDA 510(k) clearance for the LO-BAK TRAX, a Apparatus, Traction, Non-powered (Class I — General Controls, product code HST), submitted by Roland F Berthiaume, DC (Springfield, US). The FDA issued a Cleared decision on August 2, 2011, 127 days after receiving the submission on March 28, 2011. This device falls under the Neurology review panel. Regulated under 21 CFR 888.5850.

Submission Details

510(k) Number	K110858 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2011
Decision Date	August 02, 2011
Days to Decision	127 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF