BACK-ON-TRAC, MODEL 101BOT— 510(k) K984190

Substantially Equivalent

Back-On-Track, Inc.

FDA 510(k) clearance K984190 for BACK-ON-TRAC, MODEL 101BOT, Substantially Equivalent on 1999-03-15. Applicant: Back-On-Track, Inc..

Clearance details

Applicant: Back-On-Track, Inc.
Product code: Code HST
Advisory panel: Orthopedic
Date received: 1998-11-23
Decision date: 1999-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Charles, MO, 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.