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510(k) Data Aggregation
K Number
K033193Device Name
SONOSENS
Manufacturer
FRIENDLY SENSORS AG
Date Cleared
2004-01-23
(113 days)
Product Code
NKI
Regulation Number
888.1500Why did this record match?
Applicant Name (Manufacturer) :
FRIENDLY SENSORS AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Continuous real-time measurement of range of motion.
Device Description
The sonoSens® is a non-invasive device indicated for use in real-time measurement of range of motion. The measuring device consists of a monitor central processing unit (CPU), the power supply, and an infrared interface for data transfer. The device is connected to eight sensors via cables. Each sensor is directly attached to the skin with an adhesive pad.
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