(90 days)
Not Found
Not Found
No
The summary describes a simple infrared energy emitting device for topical temperature, with no mention of AI, ML, image processing, or data analysis that would typically indicate AI/ML involvement.
Yes
The device is intended for therapeutic benefits such as relief of muscle and joint stiffness, increased circulation, and muscle relaxation, which are all therapeutic claims.
No
The intended use describes therapeutic benefits (relief of stiffness, increased circulation, muscle relaxation) rather than diagnosing conditions.
No
The intended use explicitly states the device "emit[s] energy in the infrared spectrum," which requires hardware to generate and emit infrared light. This is not a software-only function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device that applies infrared energy to the body for therapeutic purposes (relief of muscle/joint stiffness, increased circulation, muscle relaxation). This is a therapeutic device, not a diagnostic one.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- Lack of IVD-related information: The provided information lacks any mention of analyzing biological samples, diagnostic purposes, or any of the typical components or processes associated with IVDs.
Therefore, based solely on the provided text, this device falls under the category of a therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
To emit energy in the infrared spectrum to provide topical To emit energy in the infract bpood and the many temperature. Intended to use for the temporary relief of minor muscle and joint stifthess, cemporary increase in local relief of minor strain spasm, cemporary increase a circulation where applied, and the relaxation of muscles.
Product codes
ILY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Not Found
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).
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three wavy lines beneath it, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 28 1999
Mr. Daniel Ye Hua, MBA President United Pacific Company, Ltd. 219 South Raymond Avenue Alhambra, California 91801
K991503 Re: Trade Name: Sacred Crane TDP Lamp Regulatory Class: II Product Code: ILY Dated: April 24, 1999 Received: April 29, 1999
Dear Mr. Ye Hua:
We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Daniel Ye Hua, MBA
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely yours,
Neil R.P. Ogden
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 8 of 32
510(k) Number (if known):_K991503
Device Name: SACRED CRANE TDP LAMP
Indications For Use:
To emit energy in the infrared spectrum to provide topical To emit energy in the infract bpood and the many temperature.
Intended to use for the temporary relief of minor muscle and joint stifthess, cemporary increase in local relief of minor strain spasm, cemporary increase a
circulation where applied, and the relaxation of muscles.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ARO
| Division Sign-Off | |
|---|---|
| Division of General Restorative Devices | K991503 |
| 510(k) Number |
Prescription Use_
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)