(39 days)
Not Found
No
The document describes a standard heating pad and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is intended for "the temporary relief of minor muscle and joint pain and stiffness," "temporary relief of joint pain associated with arthritis," and "muscular relaxation," which are therapeutic benefits.
No
The device is a heating pad intended for pain relief and muscular relaxation through topical heating, not for diagnosing medical conditions.
No
The device description clearly states it is a "Heating Pad" consisting of physical components like an outer cover, faux leather, and polyfiber fabric blend, which are hardware. The performance studies also focus on physical properties and electrical safety, not software performance.
Based on the provided information, the Therasage™ Heating Pad is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing topical heating to the user for the relief of pain, stiffness, muscle spasms, etc. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a heating pad that provides infrared heat to the body. This aligns with a physical therapy or comfort device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a disease or condition.
- Performance Studies: The performance studies focus on the device's functionality, safety, and durability as a heating pad, not on its ability to accurately diagnose or detect something in a biological sample.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Therasage™ Heating Pad operates in vivo (on the body) and provides therapeutic benefits.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ILY, IRT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Any exterior locations where the application of heat would be helpful
Indicated Patient Age Range
Persons over 10; persons who are not infants, invalids, unconscious, sleeping, or with poor circulation.
Intended User / Care Setting
Home, Office, or similar locations
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5500 Infrared lamp.
(a)
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.(b)
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.
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
HEATING PAD | RICHWAY
INTERNATIONAL
BIO-MAT 2000
(obtained from
labeling
information) | THERMOTEX
THERAPY
HEAT SYSTEM
(obtained from
labeling
information) | OTHER
NOTES | |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------|
| FUNCTION | Distributes far
infrared heat to
user | Distributes far
infrared heat to
user | Distributes far
infrared heat to
user | | |
| DESIGN | Small blanket
design with jade
stones on one
side | Blanket or mat
design with
amethyst crystals
on one side | Outer
application
cover with
adjustable pads | See Note 3 | |
| Intended for over
the counter use and
not prescription use | Yes | Yes | Yes | | |
| contains components
derived from a
biologic source | No | No | No | | |
| Is device provided
sterile? | No | No | No | | |
| Is device intended for
single use? | No | No | No | | |
| Is device a
reprocessed single
use device? | No | No | No | | |
| does device contain
a drug? | No | No | No | | |
| | | | | | |
| does device contain
a biologic? | No | No | No | | |
| does device use
software? | Yes | Yes | Yes | | |
| Is device implanted? | No | No | No | | |
| MATERIAL | Primarily
polyurethane
(exterior) and
cotton padding
(interior) | Silk-cotton blend
(17 layers of
material) | Nylon-cotton
blend | | |
| ELECTRICAL
SAFETY | Electrical
Safety Testing
Based upon
standards of
IEC60601-1
IEC 60601-1-2 | Undisclosed | Undisclosed | See Note 4 | |
| POWER SOURCE | Electrical
Current,
100-120v, 5
amps, 45-480
w. 50/60 Hz | Electric Current,
100-120v, 5
amps, 50/60 Hz
100-330 watts | Electric Current,
100-120v,
8-35 watts | | |
| WHERE USED | Home, Office,
or similar
locations | Home, Office, or
similar locations | Home, Office,
or similar
locations | | |
| | INTERFACE | See Note 1
Below | See Note 1 Below | See Note 1
Below | |
| | ENERGY
DELIVERED | $35 +^{\circ}C$ to
$60.5 +^{\circ}C$ | 35 °C to 70°C | 40° C - 45°C | |
| | STANDARDS MET | ISO 14971
IEC 60601-1
IEC 60601-1-2
ISO
10993/G95-1
ISO 10993-18 | Undisclosed | Undisclosed | Note 4 |
| | FDA PRODUCT
CODE | ILY | ILY | ILY | |
| | TARGET
POPULATIONS | Persons over
10; persons
who are not
infants, invalids,
unconscious,
sleeping, or with
poor circulation. | Persons who are
not infants,
invalid,
unconscious,
sleeping, or those
with poor
circulation. | Persons who
are not infants,
invalid,
unconscious,
sleeping, or
those with poor
circulation. | |
| | | | | | |
| ANATOMICAL
USAGE | Any exterior
locations where
the application
of heat would
be helpful | Any exterior
locations where
the application of
heat would be
helpful | Any exterior
locations where
the application
of heat would
be helpful | | |
| BIOCOMPATIBILITY | Testing through
NAMSA
completed
pursuant to
ISO 10993-18 | Note 2 | Laboratory bench
testing and
animal testing
performed to
demonstrate
"infrared radiation
capability and
safety" (See, 510
K Summary) | See Note 3 | |
| STERILITIY | None (external
use only) | None (external
use only) | None (external
use only) | | |
| COMPATIBIITY
WITH
ENVIRONMENT | Fully compatible
with an inside
environment | Fully compatible
with an inside
environment | Fully compatible
with an inside
environment | | |
| DURATION OF USE | Personal
preference | Personal
preference | 30-45 minute
recommended
treatment time | | |
| MAX
TEMPERATURE ON
THE SKIN | 41°C | Undisclosed | Undisclosed | | |
| MAXIMUM TIME
SETTING | 6 hours | Undisclosed | Undisclosed | | |
| TIME SETTING
INTERVALS | 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, and
Queen Sizes | Varies based on
model and
treatment
modality | | |
| METHOD OF
GENERATING FIR
HEAT | Electrical wiring
and heating
element. | Undisclosed | Undisclosed | | |
| SAFETY
FEATURES | Auto shut-off on
timer; heat
sensor for
potential over-
heating; surge
protector built
into device | Auto time shut off
feature | Safety
Certifications
from CSA-USA,
CE, and UL
(See Appendix
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)
(Division Sign-Off) (Division Sign of Surgical, Orthopedic, and Restorative Devices
510(k) Number__