DeviceClearance

K221865

Substantially Equivalent

BTL-094

Applicant
BTL Industries, Inc.
Product code
ISA
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Marlborough, MA, US
Download summary PDF View 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.