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.

Device 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.

AI/ML Overview

The Therasage Heating Pad is a medical device designed to provide topical heating to the user. The study provided in the document focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against defined acceptance criteria through a clinical or performance study. Therefore, detailed information on acceptance criteria and a study proving those criteria are met is not explicitly available in the provided text in the way a traditional clinical trial report would present it.

However, based on the provided text, we can infer the "acceptance criteria" were primarily demonstrating conformity to safety standards and functional equivalence to predicate devices through nonclinical testing and comparison of technological characteristics.

Here's an attempt to structure the information based on your request, with the understanding that direct "acceptance criteria" are not numerically stated and the "study" is primarily a nonclinical comparison and safety testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Submission)	Reported Device Performance (as demonstrated in the submission)
Safety and Functional Equivalence to Predicate Devices: - Same intended uses and similar indications. - Similar technological characteristics (function, design, materials, power source, usage environment, anatomical usage, sterility, environmental compatibility). - Similar target populations. - No new questions of safety or effectiveness raised by technological, aesthetic, or ancillary differences.	The Therasage Heating Pad is described as "substantially similar" to the Thermotex Heat Therapy Systems (K092589) and the BIO-MAT 2000 (K072534). - Function: Distributes far infrared heat to user (same as predicates). - Design: Small blanket design with jade stones (similar to predicate blanket/mat designs). - Intended for OTC use: Yes (same as predicates). - Non-biologic, non-sterile, non-single-use, no drug/biologic content, not implanted: All "No" (same as predicates). - Uses software: Yes (same as predicates). - Material: Primarily polyurethane (exterior) and cotton padding (interior) – different from predicates but deemed not to raise new safety/effectiveness questions. - Electrical Safety: Based upon standards of IEC60601-1, IEC 60601-1-2 (predicates' undisclosed but original approval required compliance with then-applicable standards). - Power Source: Electrical Current, 100-120v, 5 amps, 45-480w, 50/60 Hz (similar to predicates, varying wattage). - Where Used: Home, Office, or similar locations (same as predicates). - Energy Delivered: $35+^{\circ}C$ to $60.5+^{\circ}C$ (within range of predicates). - Standards Met: ISO 14971, IEC 60601-1, IEC 60601-1-2, ISO 10993/G95-1, ISO 10993-18 (predicates' undisclosed but original approval required compliance). - FDA Product Code: ILY (same as predicates). - Target Populations: Persons over 10; persons who are not infants, invalids, unconscious, sleeping, or with poor circulation (similar to predicates). - Anatomical Usage: Any exterior locations where the application of heat would be helpful (same as predicates). - Biocompatibility: Testing through NAMSA completed pursuant to ISO 10993-18 (predicates' methods undisclosed but original approval assumed compliance). - Sterility: None (external use only) (same as predicates). - Compatibility with Environment: Fully compatible with an inside environment (same as predicates). - Duration of Use: Personal preference (similar to predicate). - Max Temp on Skin: 41°C (predicates undisclosed, but within expected therapeutic range). - Maximum Time Setting: 6 hours (predicates undisclosed). - Time Setting Intervals: 15 minutes (predicates undisclosed). - Sizes: Various (14"x20" to 72"x70") (similar to predicates). - Method of Generating FIR Heat: Electrical wiring and heating element (similar to predicates). - Safety Features: Auto shut-off on timer; heat sensor for potential overheating; surge protector built into device (similar to predicate features).
Performance Data / Nonclinical Testing: - Functionality - Performance - Safety - Durability - Relative Emissivity and Energy Density - Flammability - Electromagnetic Compatibility - Product Risk Evaluation - General Electrical Safety	The Therasage Heating Pad: - "functioned as intended and passed all manufacturing tests, including tests for functionability, performance, safety, and durability." - Passed "routine evaluations during manufacturing and conformance to established standards." - Results reflect "substantial equivalence with the performance of the two cited predicate devices" from testing for: - Relative Emissivity and Energy Density - Flammability - Electromagnetic Compatibility - Product Risk Evaluation - General Electrical Safety

Acceptance Criteria (Inferred from Submission)

Reported Device Performance (as demonstrated in the submission)

Safety and Functional Equivalence to Predicate Devices: - Same intended uses and similar indications. - Similar technological characteristics (function, design, materials, power source, usage environment, anatomical usage, sterility, environmental compatibility). - Similar target populations. - No new questions of safety or effectiveness raised by technological, aesthetic, or ancillary differences.

The Therasage Heating Pad is described as "substantially similar" to the Thermotex Heat Therapy Systems (K092589) and the BIO-MAT 2000 (K072534). - Function: Distributes far infrared heat to user (same as predicates). - Design: Small blanket design with jade stones (similar to predicate blanket/mat designs). - Intended for OTC use: Yes (same as predicates). - Non-biologic, non-sterile, non-single-use, no drug/biologic content, not implanted: All "No" (same as predicates). - Uses software: Yes (same as predicates). - Material: Primarily polyurethane (exterior) and cotton padding (interior) – different from predicates but deemed not to raise new safety/effectiveness questions. - Electrical Safety: Based upon standards of IEC60601-1, IEC 60601-1-2 (predicates' undisclosed but original approval required compliance with then-applicable standards). - Power Source: Electrical Current, 100-120v, 5 amps, 45-480w, 50/60 Hz (similar to predicates, varying wattage). - Where Used: Home, Office, or similar locations (same as predicates). - Energy Delivered: $35+^{\circ}C$ to $60.5+^{\circ}C$ (within range of predicates). - Standards Met: ISO 14971, IEC 60601-1, IEC 60601-1-2, ISO 10993/G95-1, ISO 10993-18 (predicates' undisclosed but original approval required compliance). - FDA Product Code: ILY (same as predicates). - Target Populations: Persons over 10; persons who are not infants, invalids, unconscious, sleeping, or with poor circulation (similar to predicates). - Anatomical Usage: Any exterior locations where the application of heat would be helpful (same as predicates). - Biocompatibility: Testing through NAMSA completed pursuant to ISO 10993-18 (predicates' methods undisclosed but original approval assumed compliance). - Sterility: None (external use only) (same as predicates). - Compatibility with Environment: Fully compatible with an inside environment (same as predicates). - Duration of Use: Personal preference (similar to predicate). - Max Temp on Skin: 41°C (predicates undisclosed, but within expected therapeutic range). - Maximum Time Setting: 6 hours (predicates undisclosed). - Time Setting Intervals: 15 minutes (predicates undisclosed). - Sizes: Various (14"x20" to 72"x70") (similar to predicates). - Method of Generating FIR Heat: Electrical wiring and heating element (similar to predicates). - Safety Features: Auto shut-off on timer; heat sensor for potential overheating; surge protector built into device (similar to predicate features).

Performance Data / Nonclinical Testing: - Functionality - Performance - Safety - Durability - Relative Emissivity and Energy Density - Flammability - Electromagnetic Compatibility - Product Risk Evaluation - General Electrical Safety

The Therasage Heating Pad: - "functioned as intended and passed all manufacturing tests, including tests for functionability, performance, safety, and durability." - Passed "routine evaluations during manufacturing and conformance to established standards." - Results reflect "substantial equivalence with the performance of the two cited predicate devices" from testing for: - Relative Emissivity and Energy Density - Flammability - Electromagnetic Compatibility - Product Risk Evaluation - General Electrical Safety

Detailed breakdown of the study information as per your request:

2. Sample size used for the test set and the data provenance
The submission describes nonclinical laboratory bench testing rather than a human clinical test set. The "samples" would refer to the manufactured devices tested.

Sample Size for Test Set: Not explicitly stated as a number of units. The text refers to "the Pad's performance," "the subject device," and "all manufacturing tests," implying testing was conducted on samples representing the device.
Data Provenance: Not explicitly stated (e.g., country of origin) but would be from the manufacturer's internal testing labs or contracted testing facilities (e.g., NAMSA for biocompatibility). The tests are entirely retrospective in the sense that they were conducted upon completion of the device design and manufacturing to demonstrate compliance for submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this 510(k) submission. The "ground truth" for the nonclinical tests (e.g., electrical safety, temperature output) is based on established engineering standards and measurements, not expert consensus from human observation. For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate devices.

4. Adjudication method for the test set
Not applicable. Nonclinical tests are typically evaluated against predefined specifications or standards by qualified technicians/engineers, not adjudicated by a panel of experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a heating pad, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an "algorithm only" component in the sense of AI or image interpretation. Its "software" (implied by the "does device use software?" answer) refers to its control interface (LCD screen showing temperature/time, power, fault detection), which is part of the integrated device's functionality, not a standalone algorithm being evaluated. The device's performance is inherently "standalone" in that it functions without human real-time intervention beyond initial settings.

7. The type of ground truth used
For the nonclinical tests:

Established engineering and safety standards: Such as IEC60601-1, IEC 60601-1-2, ISO 14971, ISO 10993/G95-1, ISO 10993-18.
Performance specifications: Manufacturer-defined limits for factors like temperature output, emissivity, flammability, and electromagnetic compatibility.
Predicate device characteristics: The characteristics and approved performance of the Thermotex Heat Therapy Systems (K092589) and the BIO-MAT 2000 (K072534) served as the benchmark for demonstrating substantial equivalence.

8. The sample size for the training set
Not applicable. There is no "training set" in the context of this device or its submission, as it is not a machine learning or AI-based product.

9. How the ground truth for the training set was established
Not applicable, as there is no training set.

Summary

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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:

Electric-Powered Heating Pad with Infrared Heat

Indications for Use:

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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.

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K120254
PAGE 3 OF 9

Therasage Heating Pad

510(K) Submission

TECHNOLOGICAL CHARACTERISTICS

CHARACTERISTICS	THERASAGEHEATING PAD	RICHWAYINTERNATIONALBIO-MAT 2000(obtained fromlabelinginformation)	THERMOTEXTHERAPYHEAT SYSTEM(obtained fromlabelinginformation)	OTHERNOTES
FUNCTION	Distributes farinfrared heat touser	Distributes farinfrared heat touser	Distributes farinfrared heat touser
DESIGN	Small blanketdesign with jadestones on oneside	Blanket or matdesign withamethyst crystalson one side	Outerapplicationcover withadjustable pads	See Note 3
Intended for overthe counter use andnot prescription use	Yes	Yes	Yes
contains componentsderived from abiologic source	No	No	No
Is device providedsterile?	No	No	No
Is device intended forsingle use?	No	No	No
Is device areprocessed singleuse device?	No	No	No
does device containa drug?	No	No	No

does device containa biologic?	No	No	No
does device usesoftware?	Yes	Yes	Yes
Is device implanted?	No	No	No
MATERIAL	Primarilypolyurethane(exterior) andcotton padding(interior)	Silk-cotton blend(17 layers ofmaterial)	Nylon-cottonblend
ELECTRICALSAFETY	ElectricalSafety TestingBased uponstandards ofIEC60601-1IEC 60601-1-2	Undisclosed	Undisclosed	See Note 4
POWER SOURCE	ElectricalCurrent,100-120v, 5amps, 45-480w. 50/60 Hz	Electric Current,100-120v, 5amps, 50/60 Hz100-330 watts	Electric Current,100-120v,8-35 watts
WHERE USED	Home, Office,or similarlocations	Home, Office, orsimilar locations	Home, Office,or similarlocations
	INTERFACE	See Note 1Below	See Note 1 Below	See Note 1Below
	ENERGYDELIVERED	$35 +^{\circ}C$ to$60.5 +^{\circ}C$	35 °C to 70°C	40° C - 45°C
	STANDARDS MET	ISO 14971IEC 60601-1IEC 60601-1-2ISO10993/G95-1ISO 10993-18	Undisclosed	Undisclosed	Note 4
	FDA PRODUCTCODE	ILY	ILY	ILY
	TARGETPOPULATIONS	Persons over10; personswho are notinfants, invalids,unconscious,sleeping, or withpoor circulation.	Persons who arenot infants,invalid,unconscious,sleeping, or thosewith poorcirculation.	Persons whoare not infants,invalid,unconscious,sleeping, orthose with poorcirculation.

ANATOMICALUSAGE	Any exteriorlocations wherethe applicationof heat wouldbe helpful	Any exteriorlocations wherethe application ofheat would behelpful	Any exteriorlocations wherethe applicationof heat wouldbe helpful
BIOCOMPATIBILITY	Testing throughNAMSAcompletedpursuant toISO 10993-18	Note 2	Laboratory benchtesting andanimal testingperformed todemonstrate"infrared radiationcapability andsafety" (See, 510K Summary)	See Note 3
STERILITIY	None (externaluse only)	None (externaluse only)	None (externaluse only)
COMPATIBIITYWITHENVIRONMENT	Fully compatiblewith an insideenvironment	Fully compatiblewith an insideenvironment	Fully compatiblewith an insideenvironment
DURATION OF USE	Personalpreference	Personalpreference	30-45 minuterecommendedtreatment time
MAXTEMPERATURE ONTHE SKIN	41°C	Undisclosed	Undisclosed
MAXIMUM TIMESETTING	6 hours	Undisclosed	Undisclosed
TIME SETTINGINTERVALS	15 minutes	minutes	minutes
SIZES	14" x 20" (small)21" x 30" (med)24" x 70" (large)72" x 70" (prof.)	27.5" x 74" (prof)32" x 20" (mini)Single, King, andQueen Sizes	Varies based onmodel andtreatmentmodality
METHOD OFGENERATING FIRHEAT	Electrical wiringand heatingelement.	Undisclosed	Undisclosed
SAFETYFEATURES	Auto shut-off ontimer; heatsensor forpotential over-heating; surgeprotector builtinto device	Auto time shut offfeature	SafetyCertificationsfrom CSA-USA,CE, and UL(See AppendixB)	See Note 3

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K120254

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Therasage Heating Pad 510(K)

Submission

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Therasage Heating Pad

510(K) Submission

K120254
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Therasage Heating Pad

K120254
PAGE 6 OF 9 510(K)

Submission

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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.

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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.

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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

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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.

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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

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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__

Regulation Number and Section

N/A