HVR PAIN RELIEF DEVICE

K101716 · H.V.R., Inc. · ILY · Jan 11, 2011 · Physical Medicine

Device Facts

• Record ID: K101716
• Device Name: HVR PAIN RELIEF DEVICE
• Applicant: H.V.R., Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Jan 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HVR Lamp 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.

Device Story

Handheld infrared lamp; utilizes array of 48 near-infrared (red) LEDs; emits energy in 650nm-950nm spectrum; intensity 50-80 mW/cm². Operated by user via power button; provides continuous frequency output; automatic 90-second shut-off timer. Intended for home use; patient self-administers by placing device over treatment area. Target skin temperature 39°C-45°C. Benefits include temporary pain relief, muscle relaxation, and increased local blood circulation.

Clinical Evidence

Bench testing only. Verification performed per IEC 60601-1-1-2005 to confirm functional/technical specifications and ensure skin surface temperature remains within the acceptable 39°C-45°C range.

Technological Characteristics

Handheld module; rigid ABS housing; 48 near-infrared LEDs; wavelength 650-950nm; intensity 50-80 mW/cm²; continuous waveform; power via AA batteries or AC adapter; automatic 90-second shut-off timer; effective treatment area 1000 mm².

Indications for Use

Indicated for over-the-counter use by individuals experiencing chronic pain, minor aches and pains in muscles and joints, arthritis, muscle spasms, and stiffness. Used to promote muscle relaxation and temporarily increase local blood circulation.

Regulatory Classification

Identification

An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

Special Controls

*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

• Quantum WARP 10 (K032229)

Submission Summary (Full Text)

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K 101716

# 510(k) SUMMARY HVR Lamp

JAN 1 1 201

This 510(k) summary is being submitted in accordance with 21 CFR 807.92

### 1. Submitter's Information

Name: HVR. LLC

- Address: 7821 Orion Avenue, Suite 200 Van Nuys, CA 91406 Phone: [phone] Fax: [phone]
- Contact: Jessany Garrett Director of Legal Affairs

Date Prepared: November 6. 2010

### 2. Device Information

| Trade/Proprietary Name: | HVR Pain Relief Device |
|-------------------------|---------------------------------------------------------|
| Common/Usual Name: | Infrared Lamp |
| Classification Name: | Infrared Lamp, Therapeutic Heating<br>(21 CFR 890.5500) |
| Product Code: | ILY |

### 3. Predicate Device

- . Quantum WARP 10 (K032229. November 3. 2003)
#### 4. Intended Use

The HVR Lamp 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.

## న. Device Description

The HVR Lamp is a pain relief device consisting of a hand-held module containing an array of 48 near-infrared (red) LED's, user controls and a power supply. The unit is intended to emit energy in the near-infrared spectrum for the temporary relief of pain in the muscles and joints. The HVR device operates on a continuous frequency providing

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K101716

ninety (90) seconds of treatment time per application. The user powers on the unit by pressing the power button. Once powered on, the LEDs illuminate and the user places the device over the desired treatment area. The unit automatically shuts off at the end of the treatment time. Details are provided in the Device Description Section of this submission.

## 6. Substantial Equivalence

The HVR Lamp is substantially equivalent to its predicate device when intended for use 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. The data in this 510(k) notification demonstrates that the HVR device shares the same intended use, design features and functional features and is therefore substantially equivalent to its predicate devices. There are very minor differences between the HVR Lamp and the predicate device including a more ergonomic design and larger overall unit size; however the treatment area, number and type of LEDs, light intensity and wavelength, frequency setting options and electrical safety features are the same in both devices. The minor differences between the HVR Lamp and the predicate device do not raise any new issues of safety or efficacy. A comparison of the HVR Lamp and the Quantum WARP 10 device is presented in the table below:

| HVR | Quantum WARP 10 |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Basic Device Design: Handheld module | Basic Device Design: Handheld module |
| with circular treatment area | with circular treatment area |
| Target Skin Temperature: Minimum 39° C | Target Skin Temperature: Minimum 39° C |
| and maximum 45° C | and maximum 45° C |
| Radiation: Low powered LED diodes are<br>extremely safe as Class II device | Radiation: Low powered LED diodes are<br>extremely safe as Class II device |
| Indications for use: | Indications for use: |
| The HVR Lamp is an over-the-counter | The Quantum WARP 10 Light Delivery |
| handheld device used for the treatment of | System is a handheld device used for the |
| chronic pain by emitting energy in the<br>near-infrared spectrum for the temporary | treatment of chronic pain by emitting |
| relief of minor aches and pains in muscles | energy in the near-infrared spectrum for<br>the temporary relief of minor muscles and |
| and joints, arthritis and muscle spasms, | joint pain, arthritis and muscle spasms. |
| relieving stiffness, promoting relaxation | relieving stiffness, promoting relaxation |
| of muscle tissue and to temporarily | of muscle tissue and to temporarily |
| increase local blood circulation where<br>applied. | increase local blood circulation where<br>applied. |
| | |
| Light Intensity: 50 - 80 mW/cm² | Light Intensity: 50 - 80 mW/cm² |

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K101716

| Wavelength: Near Infrared 650nm to<br>950nm | Wavelength: Near Infrared 650nm to<br>950nm |
|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Waveform: Constant | Waveform: Constant |
| Energy Delivery: Handheld treatment<br>probe; Multi diode dispersed over<br>treatment area | Energy Delivery: Handheld treatment<br>probe; Multi diode dispersed over<br>treatment area |
| Dimension: 69.85 mm x 164.3 mm x<br>77.72 mm | Dimensions: 67 mm x 141 mm x 51 mm |
| Materials: Rigid ABS | Materials: Rigid ABS |
| Effective treatment area: 1000 mm² (10<br>cm²) | Effective treatment area: 1000 mm² (10<br>cm²) |
| Diodes: 48 near-infrared (red) | Diodes: 48 near-infrared (red) |
| Frequency: One continuous setting | Frequency: One continuous setting |
| Additional safety option: 90 second<br>automatic shut off | Additional safety option: 90 second<br>automatic shut off |
| Electrical safety options: AA disposable<br>batteries and A/C wall plug adaptor, or<br>AA rechargeable batteries | Electrical safety options: AA disposable<br>batteries and A/C wall plug adaptor, or<br>AA rechargeable batteries |

# 7. Testing Summary

Testing for the HVR Lamp has been carried out to verify that the device meets all functional and technical specifications per 1EC 60601-1-1-2005 and to ensure the temperature at the skin surface where the device is applied is acceptable.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings, symbolizing protection and care. The bird is positioned within a circular border. Encircling the bird are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

HVR, LLC % Mr. Jessany Garrett Director of Legal Affairs 7821 Orion Avenue, Suite 200 Van Nuys, California 91406

JAN 1 1 2011

Re: K101716

Trade/Device Name: HVR Infrared Lamp Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: IL Y Dated: November 05, 2010 Received: November 08, 2010

# Dear Mr. Garrett:

. . . . . . .

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Mr. Jessany Garrett

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

JAN 1 1 2011

510(k) Number (if known): K (6) 716

Device Name: HVR Infrared Lamp

# 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.

Prescription Use (Parı 21 CFR 801 Subparı D)

AND/OR

Over-the-Counter Use メ (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Polen for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101716

(Division Sign-Off) Division of General Restorative Devices

510(k) Number