THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES— 510(k) K950655

Name: FDA 510(k) clearance K950655
Creator: U.S. Food and Drug Administration
Published: 1995-03-07

Substantially Equivalent for Some Indications

Ultrassage, Inc.

FDA 510(k) clearance K950655 for THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES, Substantially Equivalent for Some Indications on 1995-03-07. Applicant: Ultrassage, Inc.. Device class: 1.

Clearance details

Applicant: Ultrassage, Inc.
Product code: Code ISA
Device class: Class 1
Regulation: 21 CFR 890.5660
Advisory panel: Physical Medicine
Date received: 1995-02-01
Decision date: 1995-03-07
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Ville Mont-Royal, Quebec, CA

Download summary PDF View on FDA.gov ↗

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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.