(154 days)
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
Not Found
No
The description focuses on basic electrical and heating functions with manual controls, and there is no mention of AI or ML terms or capabilities.
Yes
The device is indicated for the temporary relief of pain associated with various musculoskeletal conditions and muscle relaxation, which are therapeutic claims.
No
Explanation: The device description and intended use indicate that the Bio-Mat is a therapeutic device for pain relief, not a diagnostic device for identifying medical conditions.
No
The device description clearly states it is an "electrically powered mattress pad" and mentions a "control panel," indicating it is a hardware device that applies infrared heat.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that applies infrared heat to the body for the temporary relief of pain and stiffness. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details an electrically powered mattress pad that applies heat. This aligns with a physical therapy or pain relief device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information about a disease or condition
- Using reagents or assays
- Performing tests in a laboratory setting
The Bio-Mat is a therapeutic device intended for direct application to the body for pain relief.
N/A
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.
Product codes
IRT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5740 Powered heating pad.
(a)
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.(b)
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.
0
Image /page/0/Picture/1 description: The image contains a logo and some text. The logo is on the left and features a stylized image of a monkey or similar animal figure. Below the figure is the word "RichWay" in a stylized font. To the right of the logo is the text "R 131 Ho PH". The text appears to be the beginning of an address or contact information.
y International, Inc.
800 FAX: 808-597-1651
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: (808)589-2800 Fax: (808)597-1651
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 |
1
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).
2
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 (240) 276-0120. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 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
4
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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number 1002534