ROTAGYM— 510(k) K832940

Substantially Equivalent

I-Rep, Inc.

FDA 510(k) clearance K832940 for ROTAGYM, Substantially Equivalent on 1983-11-07. Applicant: I-Rep, Inc..

Clearance details

Applicant: I-Rep, Inc.
Product code: Code ISD
Advisory panel: Physical Medicine
Date received: 1983-08-29
Decision date: 1983-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.