FDA 510(k)

LO-BAK TRAX

K-Number: K110858 · 2011-08-02

Decision Date2011-08-02

Product CodeHST

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LO-BAK TRAX is the device name listed in this FDA 510(k) record. The listed applicant is Roland F Berthiaume, DC. It received FDA 510(k) clearance on 2011-08-02 under 510(k) number K110858. The device is classified under product code HST. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LO-BAK TRAX?

LO-BAK TRAX is a medical device that received FDA 510(k) clearance on 2011-08-02. The listed applicant is Roland F Berthiaume, DC. The 510(k) number is K110858.

When did LO-BAK TRAX receive FDA 510(k) clearance?

LO-BAK TRAX received FDA 510(k) clearance on 2011-08-02, under 510(k) number K110858.

Who is the listed applicant for LO-BAK TRAX?

The FDA 510(k) record lists Roland F Berthiaume, DC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LO-BAK TRAX?

The FDA product code for LO-BAK TRAX is HST.

Related Devices (Code: HST)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.