(97 days)
Not Found
No
The document describes a simple infrared light therapy device with no mention of AI or ML capabilities. The testing described is for basic heat performance, not algorithmic evaluation.
Yes
The device's intended use is to provide topical heating for the temporary relief of minor muscle and joint pain, arthritis, stiffness or muscle spasms; the temporary increasing of local blood circulation and/or the temporary relaxation of muscle. These are therapeutic effects.
No
The Vevazz device is described as emitting infrared energy for therapeutic purposes (topical heating, pain relief, improved circulation, muscle relaxation), not for diagnosing medical conditions.
No
The device description explicitly details hardware components including a base unit, LED paddles, power connections, and fuses. It is not solely software.
Based on the provided information, the Vevazz device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use of the Vevazz is to provide topical heating for therapeutic purposes (pain relief, increased circulation, muscle relaxation). This is a physical therapy or therapeutic device function, not a diagnostic one.
- Device Description: The device description details the physical components and how it generates infrared energy. It does not describe any components or processes related to analyzing biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- Lack of IVD-related information: The document does not mention any aspects typically associated with IVDs, such as:
- Analysis of biological samples.
- Detection or measurement of substances in biological samples.
- Diagnosis, monitoring, or screening of diseases or conditions based on biological sample analysis.
In summary, the Vevazz is a therapeutic device that uses infrared energy for topical heating, not a device used to perform tests on biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Vevazz is a device that emits energy in the infrared spectrum and is to be used to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, stiffness or muscle spasms; the temporary increasing of local blood circulation and/or the temporary relaxation of muscle.
Product codes
ILY
Device Description
The Vevazz device is a moderately complex device that consists of a base unit that plugs into 120 VAC or 240 VAC main power with Ground (earth) and a 2 amp 250 VAC Fuse. The base unit can support up to 16 large LED paddles and 4 small LED paddles. The connections on the base are female phono jacks that are low voltage having a maximum electrical output of 16 VDC @ .5 amps for a total of 8 Watts per port. The large paddles consist of 28 LEDs in a series/parallel electrical connection that has a cord with a male phono jack. Small paddles consist of 4 LEDs and have matching electrical characteristics as the large paddles. Each LED produces 50 mw/cm2 of light energy with a wavelength of 650 nm: +/- 25 pm uniformly over the treatment area without producing hot spots.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Vevazz heat performance was tested to verify it will reach an idle temperature of 40℃ and will maintain that temperature throughout the treatment for a minimum duration of 10 minutes ±2℃. An IR camera was used to monitor skin temperature and uniformity on the abdominal region and multiple skin types.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 5, 2017
Vevazz, LLC Mr. Jamie Fettig, DC Owner 30520 Rancho California Rd, Suite 107-46 Temecula, California 92591
Re: K162763
Trade/Device Name: Vevazz Led Heat Lamp Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY Dated: November 3, 2016 Received: November 8, 2016
Dear Dr. Fettig:
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) 162763
Device Name Vevazz LED Heat Lamp
Indications for Use (Describe)
The Vevazz is a device that emits energy in the infrared spectrum and is to be used to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, stiffness or muscle spasms; the temporary increasing of local blood circulation and/or the temporary relaxation of muscle.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510-(k) Summary
1. Submitters Information
Name: Vevazz, LLC 30520 Rancho California Road Suite 107-46 Temecula, CA 92591 Tel: 773-665-4005 Contact: Jamie Fettig, Owner 773-620-9500 jamie@healthyhuman.org
2. Date Prepared:
January 3, 2017
3. Device Name and Classification
| Device | Vevazz LED Heat Lamp |
|---|---|
| Trade Name | Vevazz LED Heat Lamp |
| Regulation Description | Infrared lamp |
| Regulation Number | 21 CFR 890.5500 |
| Device Class | II |
| Review Panel | Physical Medicine |
| Product Code | ILY |
4. Intended Use
The Vevazz is a device intended to emit energy in the visible and near-IR 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.
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5. Device Description
The Vevazz device is a moderately complex device that consists of a base unit that plugs into 120 VAC or 240 VAC main power with Ground (earth) and a 2 amp 250 VAC Fuse. The base unit can support up to 16 large LED paddles and 4 small LED paddles. The connections on the base are female phono jacks that are low voltage having a maximum electrical output of 16 VDC @ .5 amps for a total of 8 Watts per port. The large paddles consist of 28 LEDs in a series/parallel electrical connection that has a cord with a male phono jack. Small paddles consist of 4 LEDs and have matching electrical characteristics as the large paddles. Each LED produces 50 mw/cm2 of light energy with a wavelength of 650 nm: +/- 25 pm uniformly over the treatment area without producing hot spots.
Predicate Devices 6.
- HVR Infrared Lamp by HVR, LLC K101716 ●
- Tanda Restore by Pharos Life Corporation K090008 .
- . HEATLUX by Home Skinnovations, LTD. - K120582
7. Technical and Performance Substantial Equivalency
The submission and predicate devices are fully compliant with USFDA recognized standards for electrical safety and emit a substantially equivalent amount of power and energy. Differences where they occur are minor and do not represent any risk or hazard.
| Performance
| Characteristic | Vevazz | HVR Lamp | Tanda Restore | HeatLux |
|---|---|---|---|---|
| Power | 50 mW/cm2 | 50-80 mW/cm2 | 60 mW/cm2 | 60 mW/cm2 |
| Wavelength | 650 nm +/- | |||
| 25nm | 650 nm to 950 nm | 870 nm | 645 nm | |
| Waveform | Constant | Constant | Constant | Constant |
| Energy Source | LED | LED | LED | LED |
| Treatment | ||||
| Area | 7.5 cm2 | 1000 mm2 (10 cm2) | 27 cm2 | 7 cm2 |
| Treatment | ||||
| Time | 17 minutes | |||
| (default) | 90 seconds | 3 minutes | 3-5 minutes | |
| Target Skin | ||||
| Temperature | 41°±2°C | 42°±3°C | 41°±2°C | 41°±2°C |
| Patient | ||||
| Contact | ||||
| Material | Rigid ABS | Rigid ABS | Rigid ABS | Rigid ABS |
8. Bench Testing Summary
The Vevazz is in compliance with the following standards:
- IEC 60601-1:2005 +C1:2006, +C2:2007, AM1:2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-2-57:2011, Medical electrical equipment Part 2-57: Particular requirements for basic safety and essential performance of non-laser lightsource equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
- IEC 62471 Ed. 1, International Standard for Photobiological Safety for Lamps and Lamp Systems - General Requirements
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IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.
9. Clinical Testing Summary
The Vevazz heat performance was tested to verify it will reach an idle temperature of 40℃ and will maintain that temperature throughout the treatment for a minimum duration of 10 minutes ±2℃. An IR camera was used to monitor skin temperature and uniformity on the abdominal region and multiple skin types.
10. Conclusion
The Vevazz is substantially equivalent to its predicate devices. Based on the technological comparison between the Vevazz and the predicates plus the human test data, it can be concluded that the Vevazz is equivalent to the identified predicates.