Clearance Summary
MEDITRODE KIT received FDA 510(k) clearance under submission number K882554, sponsored by Life-Tech Intl., 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 1988-12-23.
- Submission: K882554
- Applicant / Sponsor: Life-Tech Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5525
- Decision date: 1988-12-23
Classification & Regulation
This clearance is catalogued under FDA product code EGJ and 21 CFR 890.5525, within the Physical Medicine review panel as a Class II device.