BATHTUB TRANSFER BENCH— 510(k) K821010

Substantially Equivalent

Guardian Products Co., Inc.

FDA 510(k) clearance K821010 for BATHTUB TRANSFER BENCH, Substantially Equivalent on 1982-04-21. Applicant: Guardian Products Co., Inc..

Clearance details

Applicant: Guardian Products Co., Inc.
Product code: Code IKX
Advisory panel: Physical Medicine
Date received: 1982-04-12
Decision date: 1982-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IKX

product code IKX

Death: 11
Total: 11

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.