MU PHOTONICS PAIN THERAPIST

K012508 · Nu Photonics, Inc. · ILY · Oct 9, 2001 · Physical Medicine

Device Facts

• Record ID: K012508
• Device Name: MU PHOTONICS PAIN THERAPIST
• Applicant: Nu Photonics, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Oct 9, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

This infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This unit may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This unit may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.

Device Story

Nu Photonics Pain Therapist is a handheld infrared heat lamp; utilizes infrared and red diodes to emit pulsed infrared light; provides topical heating to elevate tissue temperature; covers approximately 11 square inches; red diodes provide visual operation indicator; includes 'Auto Off' safety feature; intended for temporary relief of minor muscle/joint pain, stiffness, arthritis, and muscle spasms; promotes local blood circulation and muscle relaxation; operated by user; device held over skin.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included functional performance and electrical leakage assessments.

Technological Characteristics

Handheld infrared lamp; infrared and red diodes; pulsed light emission; plastic housing; coverage area >11 sq inches; 'Auto Off' timer feature; electrical power source.

Indications for Use

Indicated for individuals experiencing minor muscle and joint pain, stiffness, minor arthritis pain, or muscle spasms requiring temporary relief via topical heating and increased 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

• Acubeam system (Light Force Therapy, Inc.)
• Light Patch (BioScan, Inc.)
• Photonic Stimulator (Bales Scientific, Inc.)
• Pain-X 2000 (Diomedics, Inc.)

Submission Summary (Full Text)

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# Premarket Notification [510(k)] Summary

(per 21 CFR 807.92)

#### 1. Submitted by:

Nu Photonics, Inc. P.O. Box 22599 Denver, CO 80222

| Contact Person: | William Michael Brock<br>Chairman of the Board |
|-----------------|------------------------------------------------|
| Telephone: | 303-922-9200 |
| Facsimile: | 303-922-9800 |

August 24, 2001 Date Prepared:

#### 2. Device Name

| Trade/Proprietary Name: | Nu Photonics Pain Therapist |
|-------------------------|-------------------------------------|
| Common/Usual Name: | Infrared heat lamp |
| Classification Name: | Infrared lamp (per 21 CFR 890.5500) |

#### Predicate Device: 3.

The Nu Photonics Pain Therapist is substantially equivalent to other infrared lamps on the market, such as the Acubeam system manufactured by Light Force Therapy, Inc., the Light Patch manufactured by BioScan, Inc., the Photonic Stimulator manufactured by Bales Scientific, Inc., and the Pain-X 2000, manufactured by Diomedics, Inc.

#### Intended use of the device 4.

This infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This unit may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This unit may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.

#### Description of the Device 5.

The Nu Photonics Pain Therapist consists of a collection of both infrared and red diodes packaged in a compact plastic case. The system emits pulsed light in the infrared spectrum to provide topical heating, arranged in an area covering just

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over 11 square inches. The red diodes provide a visible indication that the unit is in operation.

The system incorporates an "Auto Off" feature, in the event that the user may inadvertently leave the device on.

### Summary of the technological characteristics of the device 6. compared to the predicate device.

The Nu Photonics Pain Therapist and the above referenced predicate devices The Hu Photonios Failer in 21 CFR 890.5500. These devices utilize infrared diodes to provide topical heating for the temporary relief of muscle and/or joint unious to provide topical nealered by these devices are the same, using a similar pain. The tomporatures asimilar coverage area. The devices are handheld, and number of alouse of or the skin or held just over the skin to provide the heating.

#### Testing 7.

Testing of the Nu Photonics Pain Therapist included functional performance testing and electrical leakage testing.

#### Conclusions 8.

Based upon the testing and comparison to the predicate devices, the Nu Photonics Pain Therapist has the same intended uses, with similar technological characteristics. The system performs as intended and raises no new safety or effectiveness issues.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 92001

Nu Photonics, Inc. c/o Entela, Inc. Ned Devine, Program Manager III 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K012508

Trade/Device Name: Nu Photonics Pain Therapist Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: IL Y Dated: August 31, 2001 Received: September 28, 2001

Dear Mr. Devine:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Ned Devine

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by out of visions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with and wy of substantial equivalence of your device of your device to a legally premated predicated. The a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner goneral Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Indications for Use

Page 1 of 1

510(k) Number (if known): K 012508

Device Name: Nu Photonics Pain Therapist

Indications for Use:

This infrared heat lamp is intended to emit energy in the infrared spectrum This infrared noat lamp to the purpose of elevating tissue temperature. to provide topiou. noaling for vide temporary relief of minor muscle and This unit may be assu to provisitis pain, or muscle spasm. This unit joint pair and blimises, local blood circulation, and may be used to promote relaxation of the muscle tissue.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (per 21 CFR 801.109) OR

Mark N. Milkerson
for Division Sign Off

al. Restorative and Neurological Devices

510(k) Number

Over the Counter Use: (Optional Format 1-2-96)