HITACHI HAND HELD MASSAGER A/C POWERED— 510(k) K864088

Name: FDA 510(k) clearance K864088
Creator: U.S. Food and Drug Administration
Published: 1986-11-03

Substantially Equivalent

Hitachi Sales Corporation of America

FDA 510(k) clearance K864088 for HITACHI HAND HELD MASSAGER A/C POWERED, Substantially Equivalent on 1986-11-03. Applicant: Hitachi Sales Corporation of America. Device class: 1.

Clearance details

Applicant: Hitachi Sales Corporation of America
Product code: Code ISA
Device class: Class 1
Regulation: 21 CFR 890.5660
Advisory panel: Physical Medicine
Date received: 1986-10-21
Decision date: 1986-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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K864089 — HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA1986-11-07

Adverse events under product code ISA

product code ISA

Death: 3
Other: 1
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.