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

Substantially Equivalent for Some Indications

Ultrassage, Inc.

Clearance details

Applicant: Ultrassage, Inc.
Product code: Code ISA
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

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.