Clearance Summary
QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2B received FDA 510(k) clearance under submission number K993123, sponsored by United Pacific Co., Ltd.. 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 1999-12-17.
- Submission: K993123
- Applicant / Sponsor: United Pacific Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 1999-12-17
Classification & Regulation
This clearance is catalogued under FDA product code ILY and 21 CFR 890.5500, within the Physical Medicine review panel as a Class II device.