# K964397: Therapik

- Pathway: 510(k) (Traditional)
- Applicant: The Jenex Corporation
- Decided: Nov 4, 1997 after 365 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- Device class: 2
- Regulation: 21 CFR 890.5500
- 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 K963824 (1996). 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)
- K963824: Li's Itch Stopper, Hontech Foundation For Medical Technology (1996). Cleared while this submission was under review Summary page 1.
- (no number) Health Team Model 501500 Infrared Heater: named in the summary without a submission number
- (no number) Model HT510-500 Infrared Heater: named in the summary without a submission number
- (no number) Model NH-202 Infrared Heat Lamp: named in the summary without a submission number
- (no number) Body Relaxer Infrared Heater and Massager: named in the summary without a submission number

## Indications for use
The Therapik is indicated for use to provide temporary relief of the pain and itching resulting from insect stings and bites such as bees, wasps and mosquitoes by increasing localized blood flow.

Source page: https://510kreport.com/device/K964397
Methodology: https://510kreport.com/methodology