RTD ARM ASSISTIVE ROBOTIC DEVICE— 510(k) K993443

Substantially Equivalent

Rehabilitation Technologies Division

FDA 510(k) clearance K993443 for RTD ARM ASSISTIVE ROBOTIC DEVICE, Substantially Equivalent on 1999-12-17. Applicant: Rehabilitation Technologies Division.

Clearance details

Applicant: Rehabilitation Technologies Division
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 1999-10-12
Decision date: 1999-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, US

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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.