DeviceClearance

Product code ISA— Physical Medicine

FAMILY FITNESS SHIATSU MASSAGER

Classification name
Massager, Therapeutic, Electric
Device class
Class 1
Regulation
21 CFR 890.5660
Advisory panel
Physical Medicine
Total cleared
100
First cleared
Most recent

Market context for product code ISA

FDA has cleared 100 devices under product code ISA between 1977 and 2025, filed by 74 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code ISA

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 →

Recent clearances under product code ISA

Data sourced from openFDA. This site is unofficial and independent of the FDA.