(262 days)
Not Found
No
The summary describes a light therapy device that uses heating lamps and LEDs for pain relief. There is no mention of AI, ML, image processing, or any data-driven algorithms in the intended use, device description, or other sections. The device's function appears to be purely based on the physical properties of light and heat.
Yes.
The device is intended for therapeutic purposes such as temporary relief of pain, muscle relaxation, and increased blood circulation, which are all therapeutic actions.
No
This device is described as a pain therapy system that provides topical heating and temporary relief of muscle and joint pain. It does not perform any diagnostic functions or analyze patient data to determine a diagnosis.
No
The device description explicitly states it consists of a desktop control unit, a hand-held emitter, and a power adaptor, which are hardware components.
Based on the provided information, the TerraQuant MQ2000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a non-invasive infrared lamp for topical heating to relieve pain and improve circulation. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a system that emits light for therapeutic purposes. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- No mention of IVD characteristics: The document lacks any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing information about a patient's health status based on sample analysis.
- Mentioning reagents, assays, or laboratory procedures.
Therefore, the TerraQuant MQ2000 falls under the category of a therapeutic device, specifically a light therapy system, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TerraQuant MQ2000 Laser Therapy Device is a non-invasive infrared lamp intended to provide topical heating. The Terraquant MQ2000 in indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
Product codes (comma separated list FDA assigned to the subject device)
79GEX, ILY
Device Description
The TerraQuant MQ2000 is a non-invasive pain therapy system, which utilizes heating lamps consisting of laser, infrared, and visible red light emitting diodes (LED). It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution into one complete, compact system.
The TerraQuant MQ2000 system consists of a desktop control unit, a hand-held emitter from which the laser and other radiances are released, and a 110 V power adaptor. The laser and light therapy releases radiation with wavelengths that fall within the range as defined in 21 CFR 890.5500 for an infrared lamp.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
various areas of the body
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.
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.
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JUL 2 5 2005 510(k) Summary for TerraQuant MQ2000 Laser Therapy Device
1. SPONSOR
Escada International, Inc. 27100 Richmond Road Solon, Ohio 44139
Contact Person: Max Kanarsky Telephone: 440-542 0762
Date Prepared: March 10, 2005
2. DEVICE NAME
Proprietary Name: TerraQuant MQ2000 Laser Therapy Device Common/Usual Name: heating lamp Classification Name: Infrared lamp
3. PREDICATE DEVICES
Quantum WARP 10 Light Delivery System -- K032229
4. DEVICE DESCRIPTION
The TerraQuant MQ2000 is a non-invasive pain therapy system, which utilizes heating lamps consisting of laser, infrared, and visible red light emitting diodes (LED). It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution into one complete, compact system.
The TerraQuant MQ2000 system consists of a desktop control unit, a hand-held emitter from which the laser and other radiances are released, and a 110 V power adaptor. The laser and light therapy releases radiation with wavelengths that fall within the range as defined in 21 CFR 890.5500 for an infrared lamp.
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KO4/3055
2 of 2
5. INTENDED USE
The TerraQuant MQ2000 Laser Therapy Device is a non-invasive infrared lamp intended to provide topical heating. The Terraquant MQ2000 in indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The TerraQuant MQ2000 device and the predicate device are substantially equivalent in intended use in that they are both heating lamps intended for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated. The proposed device and predicate devices are intended to provide relief to various areas of the body depending on the site of pain.
The proposed TerraQuant MQ2000 Laser Therapy System and the predicate devices are also substantially equivalent in technological characteristics in that they all consist of hand-held, heating infrared lamps that deliver low level laser to various anatomic areas.
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Name of Manufacturer: Escada International, Inc. Laser Model Name and Number: Terraquant MQ2000
Laser Type: (Circle all that apply)
Alexandrite. Argon, CO2, Copper-Vapor, Diode, Dye, Nd:YAG, Erbium, Hol: YAG, Krypton, Ruby, KTP/532, Excimer, HENE, Accessory, Other
Indications in this application:
The TerraQuant MQ2000 is a non-invasive infrared lamp intended to provide topical heating. The TerraQuant MQ2000 is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
FDA Document Control Number: K043055
FDA Product Code: 79GEX
Reviewer Computer Initials: CYH
Date of Clearance Letter: 07/18/05
Basis of Approval: (Circle all that apply)
Predicate Device (PD), Clinical Data (CD), Animal Data (AD), Specifications (SPECS), Bench Test Data (BTD), Historical Information (HI), Other
Description of Laser: Operation Modes: (Circle all that apply) CW, Pulsed, Q-Switched, Mode Locked, Contact, Free Beam, Other
Wavelength in Nanometers: 900, 860-960, 600-700
Power/Energy Range (Watts/Joules): 60-90 mW
Pulse Width:
Repitition Rate:
Delivery System: hand held emitter Comments:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The seal is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 25 2005
Escada International, Inc. c/o Ms. Mary McNamara-Cullinane, RAC Medical Device Consultants, Inc. . . 49 Plain Street North Attleboro, Massachusetts 02760
$
Re: K043055
Trade/Device Name: TerraQuant MQ2000 Laser Therapy Device Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: July 5, 2005 Received: July 6, 2005
Dear Ms. McNamara-Cullinane:
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 such 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); 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.
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Page 2- Mary McNamara-Cullinane, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and by John finding of substantial equivalence of your device to a legally predicated 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
E.A.
Miriam C. Provost, Ph.D.
Miriam C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
5
Indications for Use
KO43055
510(k) Number (if known):
Device Name: TerraQuant MQ2000 Laser Therapy Device
.. .
Indications for Use:
The TerraQuant MQ2000 is a non-invasive infrared lamp intended to provide topical heating. The Terraquant MQ2000 is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Eula A
Jon Sign-Off) vision of General, Restorative rd Neurological Devices
March 10, 2005