BACK TRAC— 510(k) K781647

Substantially Equivalent

Tech Engineering, Inc.

FDA 510(k) clearance K781647 for BACK TRAC, Substantially Equivalent on 1978-10-17. Applicant: Tech Engineering, Inc..

Clearance details

Applicant: Tech Engineering, Inc.
Product code: Code HST
Advisory panel: Orthopedic
Date received: 1978-09-27
Decision date: 1978-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.