(73 days)
The device may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The "CHUNG CHENG " Far Infrared Ray healthful Lamp (or Medical FIR Radiator) Model #CH-8810 can be used to emit topical heating to the body of human. The device make use of a "All In One" Automatic control Temperature Ceramic Semiconductor. Emission spectrum ranges from 4 to 14 microns. The device uses 120Vac as power source & 800W . it meets the related requirement of IEC 60601-1 Electrical Safety.
The provided text is a 510(k) summary for a medical device called the "CHUNG CHENG" Far Infrared Ray healthful Lamp (Model #CH-8810). It aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, many of the requested sections about acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies are not applicable to this type of submission. The device is being cleared based on its similarity in intended use and technological characteristics to an already legally marketed device, and conformity to applicable electrical safety standards.
Here's a breakdown of what can be extracted and what is not available from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document as it's a 510(k) summary focused on substantial equivalence, not a detailed performance study against specific acceptance criteria. The performance summary only states: "The device conforms to applicable standards includes IEC 60601-1, IEC 60601-1-2 & related standards ---- etc." This indicates compliance with electrical safety and electromagnetic compatibility standards, not clinical performance metrics like sensitivity, specificity, or reader agreement.
2. Sample size used for the test set and the data provenance:
Not applicable/Not provided. This document does not describe a clinical test set or study involving human participants to evaluate performance metrics. The clearance is based on comparison to a predicate device and bench testing for electrical safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Not provided. No clinical test set requiring expert ground truth is mentioned.
4. Adjudication method for the test set:
Not applicable/Not provided. No clinical test set is mentioned.
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/Not provided. This device is an infrared lamp for topical heating, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/Not provided. This is not an algorithm-based device.
7. The type of ground truth used:
Not applicable/Not provided. No clinical ground truth is established for this type of device. The "ground truth" for its safety and effectiveness is established by its substantial equivalence to a predicate device and compliance with relevant safety standards.
8. The sample size for the training set:
Not applicable/Not provided. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable/Not provided. Not an AI/machine learning device.
Summary of Device and Evidence for Substantial Equivalence:
The "CHUNG CHENG" Far Infrared Ray healthful Lamp (Model #CH-8810) is an infrared heating lamp intended for:
- Temporary relief of minor muscle and joint pain and stiffness.
- Temporary relief of joint pain associated with arthritis.
- Temporary increase in local circulation where applied.
- Relaxation of muscles.
- Assistance with muscle spasms, minor sprains and strains, and minor muscular back pain.
The study proving the device meets acceptance criteria (in the context of a 510(k) clearance) is the bench testing that demonstrated compliance with applicable standards (IEC 60601-1, IEC 60601-1-2 & related standards for electrical safety) and the comparison to a predicate device.
- Predicate Device: FIRARD II/ TDP LAMP (K960036) marketed by HELIO MEDICAL SUPPLIES, INC.
- Basis for Substantial Equivalence: The submission states that the new device has "the same intended use and similar technological characteristics" as the predicate device. It further claims that "bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." This means the product's safety and effectiveness are inferred from its similarity to an already approved device and its adherence to relevant safety standards.
{0}------------------------------------------------
510(K) SUMMARY
K053761/2
FEB 1 6 2000
nis 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's Name: CHUNG CHENG ELECTRIC HEATING CO., LTD.
- no. 39 huan kung RD., Yung Kang Industrial Address: area, yung kang city, tainan hsien, taiwan +886-6-2314078 Phone: +886-6-2330916 Fax: Mr. C.T. Chang/President Contact:
-
- Device Name :
"CHUNG CHENG " Far Infrared Ray healthful Lamp Trade Name: (or Medical FIR Radiator) Model #CH-8810 Common Name: Infrared Heating Lamp
Classification name Lamp, Infrared
"CHUNG CHENG " Far Infrared Ray healthful Lamp (or 2 DEVICE CLASS Medical FIR Radiator) Model #CH-8810 have been classified as Requlatory Class: II Product Code: ILY Panel : Physical Medicine Requlation Number: 21CFR 890.5500
The predicate device is the 4. Predicate Device: · FIRARD II/ TDP LAMP (K960036) marketed by HELIO
MEDICAL SUPPLIES, INC.
- Device Description: The "CHUNG CHENG " Far Infrared Ray healthful Lamp (or Medical FIR Radiator) Model #CH-8810 can be used to emit topical heating to the body of human. The device make use of a "All In One" Automatic control Temperature Ceramic Semiconductor. Emission spectrum ranges from 4 to 14 microns. The device uses 120Vac as power source & 800W . it meets the related requirement of IEC 60601-1 Electrical Safety.
{1}------------------------------------------------
K053376 2/2
- Intended Use: The "CHUNG CHENG " Far Infrared Ray healthful Lamp (« Medical FIR Radiator) Model #CH-8810 may be used for the temporary relief of minor muscle and joint pain and stiffness. the temporary relief of joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
-
- Performance The device conforms to applicable standards includes IEC Summary: 60601-1, IEC 60601-1-2 & related standards ---- etc.
-
- Conclusions:
The "CHUNG CHENG " Far Infrared Ray healthful Lamp (or Medical FIR Radiator) Model #CH-8810 has the same intended use and similar technological characteristics as the FIRARD II/ TDP LAMP (K960036) marketed by HELIO MEDICAL SUPPLIES, INC.. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the "CHUNG CHENG " Far Infrared Ray healthful Lamp (or Medical FIR Radiator) Model #CH-8810 is substantially equivalent to the predicate devices.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES · USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 2006
Chung Cheng Electric Heating Co., Ltd. c/o Ms. Jennifer Reich Harvest Consulting Corp. 2904 N. Boldt Drive Flagstaff, Arizona 86001
Re: K053376
R05370
Trade/Device Name: "CHUNG CHENG" Far Infrared Ray healthful Lamp (or Medical FIR Radiator) Model #CH-8810
Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: January 26, 2006 Received: February 6, 2006
Dear Ms. Reich:
We have reviewed your Section 510(k) premarket notification of intent to market the device w oneve 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 about in 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, de nees mat have been reauire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merers, mains 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 if your device to such additional controls. Existing major regulations affecting your device can may or babyer to back as a sateral 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 r read o o a mode 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 sct Errth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in and quarty of brovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
Page 2 - Ms. Reich
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin maneting your antial equivalence of your device to a legally premarket nothleadon: The PDF miaing of basification 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 If you desire specific advice for your ac not on one of on the regulation entitled, connact the Office of Compullion in (21 m (21 CFR Part 807.97). You may obtain Missionaliding by reference to premance notifications in the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Hubert Lemmens
Mark N. Melkerson Acting 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 (if known): K 05 3 3 76
Device Name: "CHUNG CHENG " Far Infrared Ray healthful Lamp
Device Name: "CHUNG CHEVE Barlieter) Model #CH-8810 CHONG ORENO ORDERS Model #CH-8810 (or Medical PIX Raulars)
CHUNG CHENG ELECTRIC HEATING CO., LTD.
Indications For Use:
The device may be used for the temporary relief of minor muscle and joint pain a
rther and the first and the taming secsioned with arthritis, the temporar The device may be used for the temporary rollor with atthritis, the temporary stiffness, the temporary relier of joint punt purcessation of muscles. In addition
increase in local circulation where applied, and relaxation and minor increase in local circulation where applied, and really and strains, and minor muscular back pain.
| Prescription Use(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use(21 CFR 807 Subpart C) | V |
|---|---|---|---|
| ------------------------------------------------- | -------- | ------------------------------------------------ | --- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1
510(k) Number__________
N/A