Clearance Summary
ANALGESIC PULSER, MODEL AP-439 received FDA 510(k) clearance under submission number K993229, sponsored by Johari Electro-Tech Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-02-02.
- Submission: K993229
- Applicant / Sponsor: Johari Electro-Tech Co.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2001-02-02
Classification & Regulation
This clearance is catalogued under FDA product code GZJ and 21 CFR 882.5890, within the Neurology review panel as a Class II device.