PULSESTAR EXERCISE BIKE— 510(k) K863884

Name: FDA 510(k) clearance K863884
Creator: U.S. Food and Drug Administration
Published: 1986-10-23

Substantially Equivalent

Battle Creek Equipment Co.

FDA 510(k) clearance K863884 for PULSESTAR EXERCISE BIKE, Substantially Equivalent on 1986-10-23. Applicant: Battle Creek Equipment Co.. Device class: 2.

Clearance details

Applicant: Battle Creek Equipment Co.
Product code: Code ISD
Device class: Class 2
Regulation: 21 CFR 890.5360
Advisory panel: Physical Medicine
Date received: 1986-10-06
Decision date: 1986-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Battle Creek, MI, US

Download summary PDF View on FDA.gov ↗

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K882264 — BATTLE CREEK PILLOW1988-08-09
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K851237 — THERMOPHORE ELECTRIC FOMENTATION UNIT1985-07-29
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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.