(188 days)
Not Found
No
The summary describes a simple heat therapy device and does not mention any AI or ML components or capabilities.
Yes
The device is indicated for the temporary relief of pain and stiffness, muscular relaxation, and temporary increase of local circulation, all of which are therapeutic purposes.
No
The device description and intended use indicate that it is a heat therapy system for pain relief and circulation, not for diagnosing medical conditions.
No
The device description explicitly states the system consists of an outer application cover with adjustable pads enclosing infrared heating elements, indicating a hardware component is central to its function.
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 heat to the body for therapeutic purposes (pain relief, muscle relaxation, increased circulation). This is a direct interaction with the patient's body.
- Device Description: The description details a system that provides infrared heat to different areas of the patient's body using pads and heating elements. This is a physical therapy device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVD devices are used to examine specimens from the body to provide information about the body's state.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FIR Heat Therapy Systems are indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.
Product codes
IRT, ILY
Device Description
The FIR Heat Therapy Systems provide infrared heat to different areas of the patient's body. The Systems consist of an outer application cover with adjustable pads that enclose the infrared heating elements to treat different areas of the body. The pad's covers are fabricated of nyloncotton blend. Velcro fasteners on the cover allow for adjusting the cover and pads for optimum contact to the patient's body areas.
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
We have provided the performance tests including the skin temperature test and the infrared energy and spectrum test to support the safety and effectiveness of the subject device.
The spectrum test shows that the subject device emits the main infrared electromagnetic spectrum 5~15 microns, with center around 9 microns.
The infrared energy test (Thermal Distribution Map) shows that the core temperature range of heating pad is about 44°C.
The skin temperature test shows that the time for skin surface to reach therapeutic temperature range 40°C is about 5 minutes; the time to reach maximum temperature 42°C is about 10 minutes.
Key Metrics
Not Found
Predicate Device(s)
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
NOV - 8 2011
Sponsor: Shenzhen Anpan Technology Co., Ltd. Subject Device: FIR Heat Therapy Systems Supplemental Information 3 for Response the 3d FDA Comment File No.:
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.
1. Submitter Information
Sponsor Name: Shenzhen Anpan Technology Co., Ltd. Address: No. 44, 2nd Road, XiaKeng, TongLe Community, LongGang Town, LongGang District, 518116 Shenzhen, China Contact Person: Mr. Wang Tao (Certification Engineer) Tel: +86-755-8964 0313-862 Fax: +86-755-2570 0826 Email: wangtao3801495@126.com
Application Correspondent Information:
MEDLAB (Shenzhen) Information Service Co., Ltd. Address: Room 2706, Block A, ZhongFang JinYuan Buiding, Xinwen Road, Shenzhen, Guangdong, P.R. China, 518034 Contact Person: Ms. Sabrina Wei (Manager) Tel: +86-755-8308 9699 Fax: +86-755-8632 9134 Email: sabrinawei@hotmail.com
2. Subject Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Common Name: | Powered heating pad and infrared lamp |
| Trade Name: | FIR Heat Therapy Systems |
| Models: | EH-6601, EH-6603, EH-6604, EH-6605, EH-6606, EH-6607, |
| EH-6608, EH-6609, EH-6610, EH-6611, EH-6612, EH-6613, | |
| EH-6614 | |
| Classification Name: | Powered heating pad and infrared lamp |
| Review Panel: | Physical Medicine |
| Product Code: | IRT, ILY |
| Regulation Number: | CFR 890.5740, 890.5500 |
| Regulation Class: | 2 |
1
3. Predicate Device Information
| Sponsor: | EAS Consulting Group LLC. |
|---|---|
| Device Name: | Thermotex Heat Therapy Systems |
| 510(k) Number: | K092589 |
| Product Code: | IRT, ILY |
| Regulation Number: | CFR 890.5740, 890.5500 |
| Regulation Class: | 2 |
4. Device Description
The FIR Heat Therapy Systems provide infrared heat to different areas of the patient's body. The Systems consist of an outer application cover with adjustable pads that enclose the infrared heating elements to treat different areas of the body. The pad's covers are fabricated of nyloncotton blend. Velcro fasteners on the cover allow for adjusting the cover and pads for optimum contact to the patient's body areas.
5. Intended Use
The FIR Heat Therapy Systems are indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.
6. Conformity Standards
The manufacturer has evaluated the subject device by lab testing according to the following standards:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, � 1988+A1:1991+A2:1995
- . IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. 2007
- � ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, 2009
- . ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity, 2009
- � ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity, 2002+A1:2006
2
7. Determination of Substantial Equivalence
Compare with predicate device, the subject device is very similar in design principle, intended use, indication for use, the applicable standards, infrared electromagnetic spectrum and therapeutic temperature range.
The difference for the key specifications listed in the following table will not affect the safety and effectiveness for the subject device.
| Item | Predicate Device | Subject Device | Note |
|---|---|---|---|
| Device Name | Thermotex Heat Therapy | ||
| Systems | FIR Heat Therapy Systems | -- | |
| Design Principle | FIR (far-infrared) therapy | FIR (far-infrared) therapy | Same |
| Patient Contacting | |||
| Material | Velours (nylon face cover, | ||
| 50/50 nylon/cotton back) | Nylon-cotton blend pad | ||
| ABS plastic cover | |||
| Nylon Velcro fastener | Note 1 | ||
| Energy Source | 110Vac, 50W | 6Vdc (4 x "AA" alkaline | |
| batteries), 8W (maximum) | Note 2 | ||
| Heating Element | Carbon black fiberglass | ||
| (glass-fabric impregnated with | |||
| electric conducting plastic | |||
| "PTFE-Carbon") | Carbon fibre | Note 3 | |
| Infrared | |||
| Electromagnetic | |||
| Spectrum | 5~15 microns, with center | ||
| around 9 microns | 5~15 microns, with center | ||
| around 9 microns | Same | ||
| Therapeutic | |||
| Temperature Range | 40~45 °C | 40~45 °C | Same |
| Approximate Skin | |||
| Temperature | 44 °C (for Low setting) | 41~42 °C | -- |
| Time to Maximum | |||
| Temperature | -- | 10 minutes | Note 4 |
| Time to Reach | |||
| Therapeutic | |||
| Temperature Range | -- | 5 minutes | |
| Recommended | |||
| Treatment Time | 30-45 minutes | 30-45 minutes | Same |
Note 1:
Although the patient contacting material of subject device is different from the predicate device, both of them are complied with ISO 10993-1. So this difference will not raise any safety or effectiveness issue.
Note 2:
Although the power supply of subject device is different from the predicate device, both of them are complied with IEC 60601-1. So this difference will not raise any safety or effectiveness issue.
3
Note 3:
Carbon black fiberglass is an E-Glass that is woven and dyed black to look like a 3K Twill Weave carbon fiber. The carbon black fiberglass does not have the strength properties of a real carbon fiber. But their far infrared thermal specification is similar, so this difference will not raise any safety or effectiveness issue,
Note 4:
Although Approximate Skin Temperature and Time to Reach Temperature Range of predicate device are different from the predicate device, they are both in the FDA generally considering therapeutic temperature range 40-45°C, so this difference will not raise any safety or effectiveness issue.
8. Performance Testing
We have provided the performance tests including the skin temperature test and the infrared energy and spectrum test to support the safety and effectiveness of the subject device.
The spectrum test shows that the subject device emits the main infrared electromagnetic spectrum 5~15 microns, with center around 9 microns.
The infrared energy test (Thermal Distribution Map) shows that the core temperature range of heating pad is about 44°C.
The skin temperature test shows that the time for skin surface to reach therapeutic temperature range 40°C is about 5 minutes; the time to reach maximum temperature 42°C is about 10 minutes.
9. Conclusion
The subject devices have all features of the predicate devices. The few differences do not affect the safety and effectiveness of the subject devices.
Thus, the subject devices are substantially equivalent to the predicate devices.
10. Summary Prepared Date: 3 November 2011
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Image /page/4/Picture/0 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 forming its body and wing. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion 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
Shenzhen Anpan Technology Co., Ltd. % MEDLAB (Shenzhen) Information Service Co., Ltd. Ms. Sabrina Wei 11900 Dulongpre Apt. 207 Street Montreal, Quebec Canada H4J 0A1
NOV - 8 2011
Re: K111273
Trade/Device Name: FIR Heat Therapy Systems, models: EH-6601, EH-6603, EH-6604, EH-6605, EH-6606, EH-6607, EH-6608, EH-6609, EH-6610, EH-6611, EH-6612, EH-6613, EH-6614 Regulation Number: 21 CFR 890.5740 Regulation Name: Powered heating pad Regulatory Class: Class II Product Code: IRT, ILY
Dated: October 19, 2011
Received: October 26, 2011
Dear Ms. Wei:
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. 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 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
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Page 2 - Ms. Sabrina Wei
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.
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melke Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Sponsor: Shenzhen Anpan Technology Co., Ltd. FIR Heat Therapy Systems Subject Device: 510(k) submission report (V1.0), Chapter 3 File No.:
Chapter 3. Indications for Use . .
Indications for Use
-- •
510(k) Number (if known):
Device Name: FIR Heat Therapy Systems, models: EH-6603, EH-6604, EH-6604, EH-6606, EH-6607, EH-6608, EH-6609, EH-6610, EH-6611, EH-6612, EH-6613, EH-6614
Indications for Use:
The FIR Heat Therapy Systems are indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.
Prescription Use_ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)
Page 1 of 1
(Division Sign-Off) (Division Sign-Old)
Division of Surgical, Orthopedic,
Division of Surgices Division of Surgers and Restorative Devices and Restorative Devices
510(k) Number K111273
Report by Shenzhen Anpan Technology Co., Ltd.
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