0 item
SSL

FDA-Cleared Safe Pain Killing Device

FDA approval for pain relief device HeatLux Pro II

FDA approved pain relief device HeatLux Pro II

 

Device Name HeatLux Pro II Device

HeatLux Pro II is an over the counter hand held device intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.

Indications for Use

Form Approved: OMB No. 0910-0120

510(k) Number K152087

Device Description:
The HeatLux Pro II Device is an over the counter, hand held device, utilizing low power light spectrum, array of 24 LEDs, at wavelength of 630±10nm and 850±50nm, RF
output power (1MHz, maximal output power 24W) and electrical heating. The HeatLux Pro II Device consists of an applicator and an adaptor. The applicator is a hand held unit
used for treatment, as the treatment surface at the applicator tip comes in direct contact with the skin. The device applicator comprises temperature stabilizer, which constantly
maintains the applicator temperature to 5° F.
Device Specifications:
RF frequency: 1MHz
Maximal RF output power: 24W
Maximal heating plates output power: 12W
Maximal optical power density: 60mWatts/cm 2
Weight: 0.6 lbs
Main Line Frequency (nominal): 50-60 Hz
Input Voltage (nominal): 100-240 VAC
Intended Use/Indication for Use:
HeatLux Pro II is an over the counter hand held device intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating
tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood
circulation, and temporary relaxation of muscles.
Performance Standards:
The HeatLux Pro II Device has been tested and complies with the following voluntary recognized standards:
• IEC 60601-1, (Third Edition, 2005 / 2006), Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-2, (Third Edition, 2007), Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility — Requirements and Tests
• IEC 60601-2-57, (First Edition, 2011), IEC 60601-2-57 (2011), Medical Electrical Equipment – Part 2-57: Particular Requirements for The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosmetic/Aesthetic Use.
• IEC 60601-2-2 Edition 5.0 2009-02, Medical Electrical Equipment – Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories.

Order it in our store.

 

Features


  • Painless Easy-to-use Portable FDA-Cleared Safe, Effective and Gentle Pain Killing Device
  • Bi-polar rf energy Deep penetration technology that reaches the muscles and joints and increases blood circulation to treat the source of the pain.
  • LED light energy LLLT – Low Light Laser Therapy to treat muscle spasms.
  • IR heat energy Dual Optical Energy – Light with dual wavelengths – Infra Red (IR) and red spectrum for treating skin pain and stiffness.
  • It’s an excellent solution for a wide range of injuries and conditions including sports and exercise injuries, acute pain and trauma, chronic or ongoing pain and everyday aches

Description


Patented Synergy Of Three Energy Sources – The Solution To Your Pain The only FDA-cleared home-use device featuring the patented synergy of 3 energy sources to gain pain relief and help the body heal itself. 3-E powerful technology: Silk’n Relief uses three different energy sources – each targeting a different depth to relieve pain by treating its source, increasing circulation and accelerating the healing process.* Bi-polar Radiofrequency (RF) Energy Deeply penetrating technology that reaches the muscles and joints and increases blood circulation to treat the source of the pain.* LLLT Energy Low Light Laser Therapy to treat muscle spasms. IR Heat Energy Light with dual wavelengths – Infra Red (IR) and red spectrum for treating pain and stiffness. The device uses specific wavelengths and bipolar RF to stimulate the body’s healing mechanisms and increase blood circulation, drawing oxygen and nutrients to the affected area. The deep heating creates an optimal healing environment that accelerates tissue regeneration and reduces inflammation, muscle aches, stiffness, and pain. The therapeutic effects may also include muscle relaxation and an improved range of motion. It’s an excellent solution for a wide range of injuries and conditions including sports and exercise injuries, acute pain and trauma, chronic or ongoing pain and everyday aches.* Silk’n Relief comes with Slider Gel – a conductive gel applied to the skin for proper delivery of the treatment that also has the benefit of allowing the device to move smoothly over the treatment area. Device packaging includes Slider Gel for conductivity and effective energy penetration. Could help for: Period pain reliever Chronic pain relief Sport pain treating Trauma pain therapy

Related Articles

sciatic nerve pain relief

Sciatic Nerve Pain Relief - Sciatica TreatmentSciatica Treatment, Causes and Symptoms Sciatica / sciatic nerve pain can potentially go ...

sciatic nerve pain relief

Low Back Strain Causes, Treatments, Exercises, Prevention   There will be the most important tips. In this post I wil...

sciatic nerve pain relief

Lower Back Strain and Sprain – Symptoms, Diagnosis and Treatments   Pulled Back Muscle and Lower Back Strain is an in...

sciatic nerve pain relief

Spinal Traction Therapy - Osteochondrosis Treatment "The spinal traction therapy are recommended to help prevent secondary deformity and t...