PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS

K081720 · Prime Herbs Corporation · ILY · Jun 16, 2009 · Physical Medicine

Device Facts

• Record ID: K081720
• Device Name: PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS
• Applicant: Prime Herbs Corporation
• Product Code: ILY · Physical Medicine
• Decision Date: Jun 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Device Story

Device is an infrared heating lamp used for topical heat therapy. It utilizes a rare earth ceramic plate to emit infrared radiation in the 2 to 50-micron spectrum. The device operates on 110V power (250W) and includes a timer and safety fuses. It is intended for the temporary relief of minor muscle and joint pain, stiffness, and muscle spasms, as well as to increase local circulation. The device is designed for use by patients or clinicians to provide localized heat to the body. The heating plate requires replacement after 1,200 to 1,500 hours of use.

Clinical Evidence

No clinical data. Substantial equivalence is based on design and technological characteristics compared to predicate devices.

Technological Characteristics

Infrared heating lamp; rare earth ceramic plate; emission spectrum 2-50 microns; 110V power; 250W; includes timer and safety fuses; no remote control; manual operation.

Indications for Use

Indicated for temporary relief of minor muscle/joint pain and stiffness, minor arthritis-related joint pain, temporary increase in local circulation, and muscle relaxation. Also indicated for muscle spasms, minor sprains/strains, and minor muscular back pain.

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

• FIRARD II TDP Lamp (K960036)
• TDP Infrared Heat Lamp (K890556)
• Sacred Crane TDP Lamp CQ27 (K991503)
• TDP CO-27 Heat Lamp (K003528)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for "Prime Herbs". The logo consists of a stylized image of a plant inside of a circle on the left, and the text "Prime Herbs" on the right. Below the text is the phrase "Healthy, Natural, Herbal" in a smaller font.

May 1, 2008

(a)(1)

Submitter:

### PRE-MARKET NOTIFICATION 510 (K) SUMMARY

(As Required by 21 CFR 807.92)

JUN 1 6 2009

Prime Herbs Corporation 1872 Hartog Drive San Jose, CA 95131

Genevieve Hsia

May 1, 2008

Contact Person:

Date Summary Prepared:

(a)(2)

Device Trade Name:

Common or Usual Name: Device Classification Name: Regulation Number: Regulation Name: Product Code: Classification: 510(k) Number:

Precision TDP Lamp; Precision Heat Lamp; Precision Infrared Lamp; Marvel Lamp; Wonder Lamp Infrared Heating Lamp lamp, infrared, therapeutic heating 21 CFR 890.5500 Infrared Lamp . ILY Class II K

#### (a)(3) Substantially Equivalent

This device is substantially equivalent in design and performance to other brands of infrared heating lamps which have been found to be substantially equivalent through the 510(k) premarket notification

| K960036 | FIRARD II TDP Lamp |
|---------|----------------------------|
| K890556 | TDP Infrared Heat Lamp |
| K991503 | Sacred Crane TDP Lamp CQ27 |
| K003528 | TDP CO-27 Heat Lamp |

Helio Medical Supplies, Inc Toxicology Professionals United Pacific Co., Lhasa Medical, Inc

2

#### (a)(4) Description

Description of Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp; Marvel Lamp and Wonder Lamp are used to provide topical heating to the body. The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp are specially engineered using a rare earth

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Image /page/1/Picture/0 description: The image shows the logo for "Prime Herbs". The logo consists of a stylized image of a plant with a circular shape around it. The text "Prime Herbs" is written in a stylized font to the right of the plant image, and below the text is the phrase "Healthy, Natural, Herbal" in a smaller font.

ceramic plate. Emission spectrum ranges from 2 to 50 microns. The emission heating plate should be replaced after 1,200 to 1,500 hours of usage. 110 volt power, 250 watts. It includes timer, safety fuses w/o remote control.

#### (a)(5) Indications for Use

The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp may be used for the temporary relief of minor muscle, joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition the Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pan.

#### (a) (6) Technological Characteristics

The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp meet the general specifications, criteria, and effectiveness for heat lamps. The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp also have the same technological characteristics as the predicate devices identified in paragraph (a)(3). The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp are identical in function, and operation; and uses the same heating plate method and design as these predicate devices,

#### (b)(1)(2)(3)

Substantial equivalence is not based on an assessment of performance data.

(c) This summary includes these 2 pages in total.

Genevieve Hsia, President

5/1/2008

**Date**

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized eagle emblem, with its wings forming a swooping, abstract shape. The logo is printed in black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 700 7 8 NUR

Prime Herbs Corporation Ms. Genevieve Hsia President 1872 Hartog Drive San Jose, California 95131

Re: K081720

Trade/Device Name: The Precision TDP Lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp

Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: ILY Dated: May 8, 2009 Received: May 14, 2009

Dear Ms. Hsia:

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 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

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Page 2- Ms. Genevieve Hsia

(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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

FOR

Mark N. Melkerson 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

510(k) Number (if known): K081720

Device Name: The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp

Indications for Use:

The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR

(21 CFR 801 Subpart C)

Page 1

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

Concurrence of CDRH, Qffice of Device Evaluation (ODE)

Willem

(Dision Sign-Off) Division of Surgical. Orthopedic. and Restorative Devices

510(k) Number K081720

(Posted November 13, 2003)