JYROCHAIR, MODEL SK-H— 510(k) K852015

Substantially Equivalent

Medco Products, Co., Inc.

FDA 510(k) clearance K852015 for JYROCHAIR, MODEL SK-H, Substantially Equivalent on 1985-07-19. Applicant: Medco Products, Co., Inc..

Clearance details

Applicant: Medco Products, Co., Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 1985-05-09
Decision date: 1985-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tinton Falls, NJ, US

Download summary PDF View on FDA.gov ↗

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.