Clearance Summary
BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) received FDA 510(k) clearance under submission number K071710, sponsored by Johnson & Johnson Consumer Products, 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 2007-08-14.
- Submission: K071710
- Applicant / Sponsor: Johnson & Johnson Consumer Products, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5710
- Decision date: 2007-08-14
Classification & Regulation
This clearance is catalogued under FDA product code IMD and 21 CFR 890.5710, within the Physical Medicine review panel as a Class I device.