(207 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of the near-infrared LEDs, with no mention of AI or ML algorithms for treatment control, analysis, or user interaction beyond a simple timer.
Yes
The device is used for the "treatment of chronic pain" and to provide "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." These are therapeutic claims.
No
The device is described as a pain relief device that emits near-infrared energy for temporary relief of aches and pains. There is no mention of it being used to diagnose any condition.
No
The device description explicitly states it is a "hand-held module containing an array of 48 near-infrared (red) LED's, user controls and a power supply," indicating it is a hardware device that emits energy.
Based on the provided information, the HVR Lamp is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for the treatment of chronic pain by emitting near-infrared energy for temporary relief of various musculoskeletal issues. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a handheld device with LEDs emitting near-infrared light for pain relief. It does not mention any components or processes related to analyzing biological samples (like blood, urine, or tissue) which is characteristic of IVD devices.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
In summary, the HVR Lamp is a therapeutic device that applies energy to the body for pain relief, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
ILY
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
muscles and joints
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5500 Infrared lamp.
(a)
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.(b)
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.
0
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: (818) 217-2556 Fax: (818) 217-3556
- 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 |
| (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
1
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 | |
| extremely safe as Class II device | Radiation: Low powered LED diodes are |
| 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 | |
| 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 |
| 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 | |
| applied. | increase local blood circulation where |
| applied. | |
| Light Intensity: 50 - 80 mW/cm² | Light Intensity: 50 - 80 mW/cm² |
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| Wavelength: Near Infrared 650nm to
950nm | Wavelength: Near Infrared 650nm to
950nm |
|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Waveform: Constant | Waveform: Constant |
| Energy Delivery: Handheld treatment
probe; Multi diode dispersed over
treatment area | Energy Delivery: Handheld treatment
probe; Multi diode dispersed over
treatment area |
| Dimension: 69.85 mm x 164.3 mm x
77.72 mm | Dimensions: 67 mm x 141 mm x 51 mm |
| Materials: Rigid ABS | Materials: Rigid ABS |
| Effective treatment area: 1000 mm² (10
cm²) | Effective treatment area: 1000 mm² (10
cm²) |
| Diodes: 48 near-infrared (red) | Diodes: 48 near-infrared (red) |
| Frequency: One continuous setting | Frequency: One continuous setting |
| Additional safety option: 90 second
automatic shut off | Additional safety option: 90 second
automatic shut off |
| Electrical safety options: AA disposable
batteries and A/C wall plug adaptor, or
AA rechargeable batteries | Electrical safety options: AA disposable
batteries and A/C wall plug adaptor, or
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.
3
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
4
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 (800) 638-2041 or (301) 796-7100 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