510(k) K033193
K033193 is an FDA 510(k) premarket notification submitted by Friendly Sensors AG for the device "SONOSENS". The FDA issued a decision of Substantially Equivalent on January 23, 2004. The device falls under product code NKI (Goniometer With Electrodes), a Class II device regulated under 21 CFR 888.1500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2004
- Date Received
- October 2, 2003
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Goniometer With Electrodes
- Device Class
- Class II
- Regulation Number
- 888.1500
- Review Panel
- NE
- Submission Type
A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording range of motion, acceleration, or forces exerted by a joint. The class II (special controls) goniometer uses transcutaneous adhesive electrode lead wires and patient cables to transmit and record patient data.