# K101716: HVR Pain Relief Device

- Pathway: 510(k) (Traditional)
- Applicant: H.V.R., Inc.
- Decided: Jan 11, 2011 after 207 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: 2 generations back to K974468 (1998). 4 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032229: Quantum Warp 10 Light Delivery System, Quantum Devices, Inc. (2003). Our reading of the summary gave K032129, FDA’s number for Radius 018 Cougar Wire (Radius Medical Technologies, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Quantum WARP 10”.

## Most influential descendants
- K120582: Heatlux (2012), 3 descendants of its own
- K150175: HeatLux Pro I (2015), 1 descendant of its own
- K251781: Kala Mini 2.0 (Kala-04) (2025), 0 descendants of its own
- K162763: Vevazz LED Heat Lamp (2017), 0 descendants of its own
- K152087: HeatLux Pro II (2016), 0 descendants of its own

## Indications for use
The HVR device is an over-the-counter handheld device used for the treatment of chronic pain by emitting energy in the near-infrared spectrum for the temporary relief of minor aches and pains in muscles and joints, arthritis and muscle spasms, relieving stiffness, promoting relaxation of muscle tissue and to temporarily increase local blood circulation where applied.

Source page: https://510kreport.com/device/K101716
Methodology: https://510kreport.com/methodology