AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM— 510(k) K994072

Substantially Equivalent

Amylior, Inc.

FDA 510(k) clearance K994072 for AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM, Substantially Equivalent on 2000-01-13. Applicant: Amylior, Inc..

Clearance details

Applicant: Amylior, Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 1999-12-02
Decision date: 2000-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Note-Dame Of Ile Perrot,Quebec, CA

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Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

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.