BIO-MAT 2000

K072534 · Richway Intl., Inc. · IRT · Feb 8, 2008 · Physical Medicine

Device Facts

• Record ID: K072534
• Device Name: BIO-MAT 2000
• Applicant: Richway Intl., Inc.
• Product Code: IRT · Physical Medicine
• Decision Date: Feb 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5740
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bio-Mat is indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis; the temporary relief of muscle spasms, minor sprains and strains, and minor muscular back pain; the relaxation of muscles; and the temporary increase of local circulation where applied.

Device Story

Bio-Mat 2000 is an electrically powered mattress pad providing infrared heat therapy. User operates via control panel to adjust temperature and timer settings. Device applies infrared heat to body to induce muscle relaxation and increase local circulation. Intended for temporary relief of minor aches, pains, and stiffness. Used in home or clinical settings by patients or clinicians. Output is thermal energy; clinical benefit is symptomatic pain relief.

Clinical Evidence

Bench testing only. 70 units underwent extensive UL testing for function, performance, safety, and durability. No clinical data provided.

Technological Characteristics

Electrically powered mattress pad; infrared heat source; user-operated control panel for temperature and timer settings. No specific material standards or software algorithm class mentioned.

Indications for Use

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

Regulatory Classification

Identification

A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E part 807 of this chapter subject to § 890.9.

Predicate Devices

• Chung Cheng Electric Far Infrared Healthful Lamp
• Lightwave Infrared Lamp
• LumiWave 1x4 Infrared Therapy Device
• AutoPrism Infrared Lamp
• KenkoWave Infrared Pain Treatment System
• Health O Meter Electric Heating Pad with Massage

Submission Summary (Full Text)

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K072534

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## y International, Inc.

800 FAX: [phone]

#### 510(k) SUMMARY

ದ್ದಾ ਾ ਲੋ

RichWay International, Inc.'s Bio-Mat 2000

#### Submitter's Contact Information

LeRoy Klima Name:

- RichWay International, Inc. Address: 1314 S. King St., Ste.520 Honolulu, Hawaii 96814
Phone: [phone] Fax: [phone]

### Name of Device and Name/Address of Sponsor

Trade Name: Bio-Mat 2000

Sponsor Contact: Calvin Kim RichWay International, Inc. 1314 S. King St., Ste. 520 Honolulu, Hawaii 96814

Common or Usual Name: Infrared heat pad for temporary relief of body aches and pains.

Classification Name: Lamp, Infrared, Therapeutic Heating (ILY) per 21 C.F.R. }890.5500

| Device Trade Name | Manufacturer |
|--------------------------------------------------|---------------------------------|
| Chung Cheng Electric Far Infrared Healthful Lamp | Chung Cheng Electric Heating Co |
| Lightwave Infrared Lamp | Skytech Enterprises, Inc. |
| LumiWave 1x4 Infrared Therapy Device | BioCare System, Inc |

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AutoPrism Infrared Lamp

KenkoWave Infrared Pain Treatment System

Health O Meter Electric Heating Pad with Massage

Rich-Mar Corporation

Kaylight Corporation

Sunbeam Health Division

## Intended Use / Indications for Use

The Bio-Mat is indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis; the temporary relief of muscle spasms, minor sprains and strains, and minor muscular back pain; the relaxation of muscles; and the temporary increase of local circulation where applied.

## Technological Characteristics

The Bio-Mat is an electrically powered mattress pad that applies infrared heat to the user's body for the temporary relief of minor body aches and pains. A control panel allows the user to turn the product on/off, modify the temperature, and set the product's timer.

## Performance Data

In all instances, the Bio-Mat functioned as intended, and passed the UL (Underwriters Laboratories) detailed/extensive tests (see Attachment 18A). These tests included the function, performance, safety, and durability of the Bio-Mat. A total of 70 Bio-Mats were eventually sent to the Underwriters Laboratories which indicates how complete the testing was.

# Substantial Equivalence

The Bio-Mat is as safe and effective as the predicate devices identified above. The Bio-Mat has the same intended uses and similar indications as the predicate devices. The technological differences between the Bio-Mat and the predicate devices that used infrared ray technology do not raise new questions of safety and effectiveness (see Substantial Equivalence Chart).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

FEB - 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

RichWay International, Inc % Mr. LeRoy Klima Consultant 1314 South King Street, Suite 520 Honolulu, Hawaii 96814

> K072534 Trade/Device Name: Bio-Mat Mattress Regulation Number: 21 CFR 890.5740 Regulation Name: Powered heating pad, Infrared lamp Regulatory Class: Class II Product Code: IRT Dated: January 03, 2008 Received: January 08, 2008

Dear Mr. Klima:

Re:

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 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.

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Page 2 -- Mr. LeRoy Klima

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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.

Mark N. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number

Device Name: Bio-Mat Mattress

#### Indications for Use:

The Bio-Mat is indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis; the temporary relief of muscle spasms, minor sprains and strains, and minor muscular back pain; the relaxation of muscles; and the temporary increase of local circulation where applied.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** 1002534