SCALP HYDROBATH/TREATMENT DELIVERY SYSTEM— 510(k) K883187

Substantially Equivalent

Intl. Health Technology, Inc.

FDA 510(k) clearance K883187 for SCALP HYDROBATH/TREATMENT DELIVERY SYSTEM, Substantially Equivalent on 1988-10-27. Applicant: Intl. Health Technology, Inc..

Clearance details

Applicant: Intl. Health Technology, Inc.
Product code: Code ILJ
Advisory panel: Physical Medicine
Date received: 1988-07-28
Decision date: 1988-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nashville, TN, US

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Adverse events under product code ILJ

product code ILJ

Death: 4
Total: 4

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.