Clearance Summary
SMART WAVE GS100 received FDA 510(k) clearance under submission number K950617, sponsored by Shotwell & Carr, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1995-10-13.
- Submission: K950617
- Applicant / Sponsor: Shotwell & Carr, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 1995-10-13
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.