THERASAGE HEATING PAD

{0}------------------------------------------------ MAR - 6 2012 K120254 PAGE 1 OF 9 Therasage Heating Pad 510(K) Submission ## 510(K) SUMMARY ### SUMMARY STATEMENT - Revised Oct/2011 Trade Name: Therasage™ Heating Pad Sponsor: Therasage, L.L.C. 21000 Boca Rio Road Suite A-21-C Boca Raton, Florida 33433 Fax: 888-416-9991 Mr. Robert Besner (888-416-4441) Contact Name: Device Generic Name: Classification: CFR 890.5500 Class II Product Code: ILY ### Product Description: The Therasage™ Heating Pad provides infrared heat to different areas of the consumer's body. The Pad consists of an outer application cover enhanced with precious stones. The Pad's cover is fabricated of faux leather and a standard polyfiber fabric blend. Electric-Powered Heating Pad with Infrared Heat ### Indications for Use: The Therasage™ Heating Pad is intended to provide topical heating to the user indicated for (a) the temporary relief of minor muscle and joint pain and stiffness: (b) the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains, and sprains, and minor muscular back pain; (c) muscular relaxation; and (d) the temporary increase of local circulation where applied. {1}------------------------------------------------ #### Therasage Heating Pad 510(K) Submission K120254 PAGE 2 OF 9 ### Predicate Devices: The Therasage™ Heating Pad is substantially similar to the: Thermotex Heat Therapy Systems (K092589), as well as the BIO-MAT 2000 (K072534) - Rich Way International Inc. ### Technological Characteristics The Therasage™ Heating Pad is an electrically-powered heating pad that generates infrared heat to affected body areas, providing temporary relief of minor muscle and joint pain. The user can control the Pad's heat and temperature to the body by means of a 3-position switch. The manufacturer has evaluated the Pad's performance during laboratory bench testing to demonstrate infrared capability and its safety. ### Summary of Technological Characteristics Compared to Predicate Devices Similarly presented as its predicate devices, Therasage™ Heating Pad continues the same technological characteristics as its predecessors. As the following chart indicates, the function, design, and component definition are all basically the same. {2}------------------------------------------------ K120254 PAGE 3 OF 9 ## Therasage Heating Pad 510(K) Submission ## TECHNOLOGICAL CHARACTERISTICS | CHARACTERISTICS | THERASAGE<br>HEATING PAD | RICHWAY<br>INTERNATIONAL<br>BIO-MAT 2000<br>(obtained from<br>labeling<br>information) | THERMOTEX<br>THERAPY<br>HEAT SYSTEM<br>(obtained from<br>labeling<br>information) | OTHER<br>NOTES | | |------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------| | FUNCTION | Distributes far<br>infrared heat to<br>user | Distributes far<br>infrared heat to<br>user | Distributes far<br>infrared heat to<br>user | | | | DESIGN | Small blanket<br>design with jade<br>stones on one<br>side | Blanket or mat<br>design with<br>amethyst crystals<br>on one side | Outer<br>application<br>cover with<br>adjustable pads | See Note 3 | | | Intended for over<br>the counter use and<br>not prescription use | Yes | Yes | Yes | | | | contains components<br>derived from a<br>biologic source | No | No | No | | | | Is device provided<br>sterile? | No | No | No | | | | Is device intended for<br>single use? | No | No | No | | | | Is device a<br>reprocessed single<br>use device? | No | No | No | | | | does device contain<br>a drug? | No | No | No | | | | | | | | | | | does device contain<br>a biologic? | No | No | No | | | | does device use<br>software? | Yes | Yes | Yes | | | | Is device implanted? | No | No | No | | | | MATERIAL | Primarily<br>polyurethane<br>(exterior) and<br>cotton padding<br>(interior) | Silk-cotton blend<br>(17 layers of<br>material) | Nylon-cotton<br>blend | | | | ELECTRICAL<br>SAFETY | Electrical<br>Safety Testing<br>Based upon<br>standards of<br>IEC60601-1<br>IEC 60601-1-2 | Undisclosed | Undisclosed | See Note 4 | | | POWER SOURCE | Electrical<br>Current,<br>100-120v, 5<br>amps, 45-480<br>w. 50/60 Hz | Electric Current,<br>100-120v, 5<br>amps, 50/60 Hz<br>100-330 watts | Electric Current,<br>100-120v,<br>8-35 watts | | | | WHERE USED | Home, Office,<br>or similar<br>locations | Home, Office, or<br>similar locations | Home, Office,<br>or similar<br>locations | | | | | INTERFACE | See Note 1<br>Below | See Note 1 Below | See Note 1<br>Below | | | | ENERGY<br>DELIVERED | $35 +^{\circ}C$ to<br>$60.5 +^{\circ}C$ | 35 °C to 70°C | 40° C - 45°C | | | | STANDARDS MET | ISO 14971<br>IEC 60601-1<br>IEC 60601-1-2<br>ISO<br>10993/G95-1<br>ISO 10993-18 | Undisclosed | Undisclosed | Note 4 | | | FDA PRODUCT<br>CODE | ILY | ILY | ILY | | | | TARGET<br>POPULATIONS | Persons over<br>10; persons<br>who are not<br>infants, invalids,<br>unconscious,<br>sleeping, or with<br>poor circulation. | Persons who are<br>not infants,<br>invalid,<br>unconscious,<br>sleeping, or those<br>with poor<br>circulation. | Persons who<br>are not infants,<br>invalid,<br>unconscious,<br>sleeping, or<br>those with poor<br>circulation. | | | | | | | | | | ANATOMICAL<br>USAGE | Any exterior<br>locations where<br>the application<br>of heat would<br>be helpful | Any exterior<br>locations where<br>the application of<br>heat would be<br>helpful | Any exterior<br>locations where<br>the application<br>of heat would<br>be helpful | | | | BIOCOMPATIBILITY | Testing through<br>NAMSA<br>completed<br>pursuant to<br>ISO 10993-18 | Note 2 | Laboratory bench<br>testing and<br>animal testing<br>performed to<br>demonstrate<br>"infrared radiation<br>capability and<br>safety" (See, 510<br>K Summary) | See Note 3 | | | STERILITIY | None (external<br>use only) | None (external<br>use only) | None (external<br>use only) | | | | COMPATIBIITY<br>WITH<br>ENVIRONMENT | Fully compatible<br>with an inside<br>environment | Fully compatible<br>with an inside<br>environment | Fully compatible<br>with an inside<br>environment | | | | DURATION OF USE | Personal<br>preference | Personal<br>preference | 30-45 minute<br>recommended<br>treatment time | | | | MAX<br>TEMPERATURE ON<br>THE SKIN | 41°C | Undisclosed | Undisclosed | | | | MAXIMUM TIME<br>SETTING | 6 hours | Undisclosed | Undisclosed | | | | TIME SETTING<br>INTERVALS | 15 minutes | minutes | minutes | | | | SIZES | 14" x 20" (small)<br>21" x 30" (med)<br>24" x 70" (large)<br>72" x 70" (prof.) | 27.5" x 74" (prof)<br>32" x 20" (mini)<br>Single, King, and<br>Queen Sizes | Varies based on<br>model and<br>treatment<br>modality | | | | METHOD OF<br>GENERATING FIR<br>HEAT | Electrical wiring<br>and heating<br>element. | Undisclosed | Undisclosed | | | | SAFETY<br>FEATURES | Auto shut-off on<br>timer; heat<br>sensor for<br>potential over-<br>heating; surge<br>protector built<br>into device | Auto time shut off<br>feature | Safety<br>Certifications<br>from CSA-USA,<br>CE, and UL<br>(See Appendix<br>B) | See Note 3 | | {3}------------------------------------------------ # K120254 PAGE 4 OF 9 #### Therasage Heating Pad 510(K) Submission {4}------------------------------------------------ ## Therasage Heating Pad 510(K) Submission K120254 PAGE 5 OF 9 {5}------------------------------------------------ ## Therasage Heating Pad K120254 PAGE 6 OF 9 510(K) Submission {6}------------------------------------------------ Therasage Heating Pad 510(K Submission SE9 Device User interfaces with device to set time and temperature for Note 1: application; LCD Controller Screen shows temperature and time setting, power, and fault detection. The biocompatibility tests performed on the predicate devices, and their Note 2: results, are not in the public domain. UL testing, however, was performed, to test successfully function, performance, safety and durability. {7}------------------------------------------------ ### Therasage Heating Pad 510(K) Submission Note 3 Any differences in appearance or structure between the subject device and the predicate devices do not raise new questions of safety and effectiveness. - Note 4 In order to obtain premarket approval, the predicate devices were required to successfully pass the then applicable electrical safety standards. The subject device has similarly satisfied the most current safety standards recognized today. ### Performance Data In all instances, the Therasage Heating Pad functioned as intended and passed all manufacturing tests, including tests for functionability, performance, safety, and durability. These tests included routine evaluations during manufacturing and conformance to established standards. The results of these nonclinical tests which reflect substantial equivalence with the performance of the two cited predicate devices arrse from testing for: Relative Emissivity and Energy Density Flammability Electromagnetic Compatibility Product Risk Evaluation General Electrical Safety In sum, the information from all of these tests and evaluations indicates without exception that the technology of the subject device and the predicate devices is substantially equivalent. Any technological, aesthetic, or ancillary differences between the Therasage Heating Pad and the predicate devices do not raise any questions of safety or effectiveness. {8}------------------------------------------------ Therasage Heating Pad 510(K) Submission ### Substantial Equivalence The subject device, as well as the indications for use and the technology upon which the device operates, is outlined above. It is a device that is substantially similar to at least two predicate devices. Such substantial equivalence presents the subject device as being as safe and effective as the predicate devices. The Therasage Heating Pad has the same intended uses and similar indications as the predicate devices. The technological differences, if any, between the Therasage Heating Pad and the predicate devices are insubstantial and are aesthetic differences, at best. No discerned technological differences exist that raise, suggest, or implicate any new questions of safety and effectiveness. Rev.11/1/2011 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Therasage, LLC % Underwriters Laboratories, Incorporated Mr. Casey Conry 1285 Walt Whitman Road Melville, New York 11747 - 6 2012 Re: K120254 Trade/Device Name: Therasage™ Heating Pad Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY, IRT Dated: January 25, 2012 Received: January 27, 2012 ### Dear Mr. Conry: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered process into 20, 1978) 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 I ou may, therefore, mance 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 I hat 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. 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. {10}------------------------------------------------ #### Page 2 - Mr. Casey Conry 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {11}------------------------------------------------ Exhibit 4.1 ## Indications for Use Form Indications for Use 510(k) Number (if known): _ Device Name: TherasageTM Heating Pad Indications for Use: The Therasage™ Heating Pad is intended to provide topical heating to the user indicated for (a) the temporary relief of minor muscle and joint pain and stiffness; (b) the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains, and sprains, and minor muscular back pain; (c) muscular relaxation; and (d) the temporary increase of local circulation where applied. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use XX (21 CFR 801 Subpart C) ### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ### Concurrence of CDRH, Office of Device Evaluation (ODE) K120254 (Division Sign-Off) (Division Sign of Surgical, Orthopedic, and Restorative Devices 510(k) Number*_*_