LO-BAK TRAX— 510(k) K110858

Substantially Equivalent

Roland F Berthiaume, DC

FDA 510(k) clearance K110858 for LO-BAK TRAX, Substantially Equivalent on 2011-08-02. Applicant: Roland F Berthiaume, DC.

Clearance details

Applicant: Roland F Berthiaume, DC
Product code: Code HST
Advisory panel: Orthopedic
Date received: 2011-03-28
Decision date: 2011-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springfield, MA, US

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Adverse events under product code HST

product code HST

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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