Bengay (R) Heat Therapy, Pain Relieving Patches/Pads (Various)
FDA 510(k) K071710 · Johnson & Johnson Consumer Products, Inc.
510(k) numberK071710
Submission
- Device name
- Bengay (R) Heat Therapy, Pain Relieving Patches/Pads (Various)
- Applicant
- Johnson & Johnson Consumer Products, Inc.
Morris Plains, NJ, US - Received
- June 22, 2007
- Decision date
- August 14, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IMD – Pack, Hot Or Cold, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5710
- Specialty
- Physical Medicine
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Questions and answers
When was Bengay (R) Heat Therapy, Pain Relieving Patches/Pads (Various) cleared by the FDA?
Bengay (R) Heat Therapy, Pain Relieving Patches/Pads (Various) (K071710) received a 510(k) decision of Substantially Equivalent on August 14, 2007, 53 days after the submission was received.
What is the product code of K071710?
The FDA product code is IMD – Pack, Hot Or Cold, Disposable, a Class I (low risk) device regulated under 21 CFR 890.5710.