UPPERCYCLE STATIONARY EXERCISE MACHINES— 510(k) K871494

Substantially Equivalent

Engineering Dynamics Corp.

FDA 510(k) clearance K871494 for UPPERCYCLE STATIONARY EXERCISE MACHINES, Substantially Equivalent on 1987-05-06. Applicant: Engineering Dynamics Corp..

Clearance details

Applicant
Engineering Dynamics Corp.
Product code
Code ISD
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lowell, MA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ISD

product code ISD
Other
2
Total
2

Source: openFDA MAUDE database, through . 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.