510(k) K890923— VITALON MATRESS MASSAGE MODEL M-MX

Substantially Equivalent

Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd.

Clearance details

Applicant
Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd.
Product code
Code ISA
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Japan 150, ID
Download summary PDFView on FDA.gov ↗

Adverse events under product code ISA

product code ISA
Death
3
Other
1
Total
4

Source: openFDA MAUDE database, through . 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.