BACK TRAC— 510(k) K781647

Name: FDA 510(k) clearance K781647
Creator: U.S. Food and Drug Administration
Published: 1978-10-17

Substantially Equivalent

Tech Engineering, Inc.

FDA 510(k) clearance K781647 for BACK TRAC, Substantially Equivalent on 1978-10-17. Applicant: Tech Engineering, Inc.. Device class: 1.

Clearance details

Applicant: Tech Engineering, Inc.
Product code: Code HST
Device class: Class 1
Regulation: 21 CFR 888.5850
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 ↗

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K872121 — K AND D HOME TRACT1987-08-12
K870212 — ARTHROSCOPIC SHOULDER HOLDER1987-02-20

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.