STANDARD HEALTH BIKE MODEL 019— 510(k) K791866

Substantially Equivalent

Battle Creek Equipment Co.

FDA 510(k) clearance K791866 for STANDARD HEALTH BIKE MODEL 019, Substantially Equivalent on 1979-10-04. Applicant: Battle Creek Equipment Co..

Clearance details

Applicant: Battle Creek Equipment Co.
Product code: Code ISD
Advisory panel: Physical Medicine
Date received: 1979-09-21
Decision date: 1979-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ISD

product code ISD

Other: 2
Total: 2

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.