BIO-MAT 2000— 510(k) K072534

Substantially Equivalent

Richway Intl., Inc.

FDA 510(k) clearance K072534 for BIO-MAT 2000, Substantially Equivalent on 2008-02-08. Applicant: Richway Intl., Inc..

Clearance details

Applicant: Richway Intl., Inc.
Product code: Code IRT
Advisory panel: Physical Medicine
Date received: 2007-09-07
Decision date: 2008-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Honolulu, HI, US

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Adverse events under product code IRT

product code IRT

Injury: 668
Total: 668

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.