Clearance Summary
TDP THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS received FDA 510(k) clearance under submission number K941675, sponsored by C.M.D. Acupuncture Center & Herbs Store. 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 1995-03-27.
- Submission: K941675
- Applicant / Sponsor: C.M.D. Acupuncture Center & Herbs Store
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5500
- Decision date: 1995-03-27
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.