(363 days)
Not Found
No
The summary describes a simple infrared heat lamp with a timer and safety features, and there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML.
Yes
The device is intended for the temporary relief of pain and stiffness, relaxation of muscles, and to help with muscle spasms, sprains, and strains, all of which are therapeutic indications. Additionally, it lists predicate devices that are also "TDP Lamps" or "Heat Lamps" which are generally considered therapeutic in nature.
No
The device description states it is used to provide topical heating to the body for pain relief and relaxation, which are therapeutic uses, not diagnostic.
No
The device description clearly outlines physical hardware components such as a ceramic plate, power requirements (110 volt, 250 watts), a timer, and safety fuses, indicating it is a hardware device that provides topical heating.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for therapeutic purposes (pain relief, circulation increase, muscle relaxation) through topical heating. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a lamp that emits infrared radiation for heating the body. This is consistent with a physical therapy or pain relief device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information.
Therefore, this device falls under the category of a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
Product codes
ILY
Device Description
Description of Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp; Marvel Lamp and Wonder Lamp are used to provide topical heating to the body. The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp are specially engineered using a rare earth ceramic plate. Emission spectrum ranges from 2 to 50 microns. The emission heating plate should be replaced after 1,200 to 1,500 hours of usage. 110 volt power, 250 watts. It includes timer, safety fuses w/o remote control.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence is not based on an assessment of performance data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K960036, K890556, K991503, K003528
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows a logo for "Prime Herbs". The logo consists of a stylized image of a plant inside of a circle on the left, and the text "Prime Herbs" on the right. Below the text is the phrase "Healthy, Natural, Herbal" in a smaller font.
May 1, 2008
(a)(1)
Submitter:
PRE-MARKET NOTIFICATION 510 (K) SUMMARY
(As Required by 21 CFR 807.92)
JUN 1 6 2009
Prime Herbs Corporation 1872 Hartog Drive San Jose, CA 95131
Genevieve Hsia
May 1, 2008
Contact Person:
Date Summary Prepared:
(a)(2)
Device Trade Name:
Common or Usual Name: Device Classification Name: Regulation Number: Regulation Name: Product Code: Classification: 510(k) Number:
Precision TDP Lamp; Precision Heat Lamp; Precision Infrared Lamp; Marvel Lamp; Wonder Lamp Infrared Heating Lamp lamp, infrared, therapeutic heating 21 CFR 890.5500 Infrared Lamp . ILY Class II K
(a)(3) Substantially Equivalent
This device is substantially equivalent in design and performance to other brands of infrared heating lamps which have been found to be substantially equivalent through the 510(k) premarket notification
| K960036 | FIRARD II TDP Lamp |
|---|---|
| K890556 | TDP Infrared Heat Lamp |
| K991503 | Sacred Crane TDP Lamp CQ27 |
| K003528 | TDP CO-27 Heat Lamp |
Helio Medical Supplies, Inc Toxicology Professionals United Pacific Co., Lhasa Medical, Inc
2
(a)(4) Description
Description of Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp; Marvel Lamp and Wonder Lamp are used to provide topical heating to the body. The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp are specially engineered using a rare earth
1
Image /page/1/Picture/0 description: The image shows the logo for "Prime Herbs". The logo consists of a stylized image of a plant with a circular shape around it. The text "Prime Herbs" is written in a stylized font to the right of the plant image, and below the text is the phrase "Healthy, Natural, Herbal" in a smaller font.
ceramic plate. Emission spectrum ranges from 2 to 50 microns. The emission heating plate should be replaced after 1,200 to 1,500 hours of usage. 110 volt power, 250 watts. It includes timer, safety fuses w/o remote control.
(a)(5) Indications for Use
The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp may be used for the temporary relief of minor muscle, joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition the Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pan.
(a) (6) Technological Characteristics
The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp meet the general specifications, criteria, and effectiveness for heat lamps. The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp also have the same technological characteristics as the predicate devices identified in paragraph (a)(3). The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp are identical in function, and operation; and uses the same heating plate method and design as these predicate devices,
(b)(1)(2)(3)
Substantial equivalence is not based on an assessment of performance data.
(c) This summary includes these 2 pages in total.
Genevieve Hsia, President
5/1/2008
Date
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized eagle emblem, with its wings forming a swooping, abstract shape. The logo is printed in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
700 7 8 NUR
Prime Herbs Corporation Ms. Genevieve Hsia President 1872 Hartog Drive San Jose, California 95131
Re: K081720
Trade/Device Name: The Precision TDP Lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp
Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: ILY Dated: May 8, 2009 Received: May 14, 2009
Dear Ms. Hsia:
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.
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 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
3
Page 2- Ms. Genevieve Hsia
(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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
FOR
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K081720
Device Name: The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp
Indications for Use:
The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR
(21 CFR 801 Subpart C)
Page 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Qffice of Device Evaluation (ODE)
Willem
(Dision Sign-Off) Division of Surgical. Orthopedic. and Restorative Devices
510(k) Number K081720
(Posted November 13, 2003)