# K071710: Bengay (R) Heat Therapy, Pain Relieving Patches/Pads (Various)

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Consumer Products, Inc.
- Decided: Aug 14, 2007 after 53 days
- Product code: IMD (Pack, Hot Or Cold, Disposable)
- Device class: 1
- Regulation: 21 CFR 890.5710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953442 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953442: Restore, Thermacells  (Hot Pack I), Neal Dunning Assoc., Inc. (1995) Summary page 1.

## Indications for use
Is intended for over-the-counter (non-prescription) use by the consumer. Provides moist heat therapy to temporarily relieve minor muscle and joint aches and pain associated with over-exertion, strains, sprains, arthritis, stiffness, and muscle spasm. Temporarily relieves minor menstrual pain. Temporarily increases local blood circulation.

Source page: https://510kreport.com/device/K071710
Methodology: https://510kreport.com/methodology
