Clearance Summary
IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1) received FDA 510(k) clearance under submission number K964977, sponsored by Interactive Living Systems, 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 1998-08-31.
- Submission: K964977
- Applicant / Sponsor: Interactive Living Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3920
- Decision date: 1998-08-31
Classification & Regulation
This clearance is catalogued under FDA product code LFF and 21 CFR 890.3920, within the Physical Medicine review panel as a Class I device.