(161 days)
Not Found
Not Found
No
The provided 510(k) summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and anatomical site suggest a physical therapy or pain relief device, not one that would inherently require AI/ML for its primary function.
Yes.
The device is indicated for providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin, which classifies it as a therapeutic device.
No
The intended use states it is for "temporary relief of minor chronic neck and shoulder pain," which indicates a therapeutic rather than diagnostic purpose.
No
The provided 510(k) summary does not contain enough information to determine if the device is software-only. The "Device Description" section is missing, which is crucial for understanding the nature of the device. The intended use suggests a physical therapy or pain relief device, which often involves hardware components.
Based on the provided information, the TUCO Erchonia PL2000 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin." This describes a therapeutic device used on the body, not a device used to examine specimens (like blood, urine, or tissue) outside the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on laboratory tests.
- Measuring analytes in specimens.
Therefore, the TUCO Erchonia PL2000 falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TUCO Erchonia PL2000 is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
Product codes
NHN
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
neck and shoulder
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
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
TUCO Innovations, Inc. C/0 Kevin Walls Regulatory Insight, Inc. 13 Red Fox Lane Littleton, Colorado 80127
Re: K012580
Trade/Device Name: TUCO Erchonia PL3000 Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, Non-Heating, for Adjunctive Use in Pain Therapy Regulatory Class: Class II Product Code: NHN Dated: November 7, 2001 Received: November 19, 2001
Dear Mr. Walls:
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 he 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.
1
Page 2 - Mr. Kevin Walls
This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow you to organization of substantial equivalence of your device to a legally prematicated predicated on: "The Promote sification 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 If you desire specific advice for your avitro diagnostic devices), please contact the Office of additionally 21 CHT Part 0671 or storestions on the promotion and advertising of Compliance at (301) 594-1057. The newslance at (301) 594-4639. Also, please note the your device, produce connect and e reference to premarket notification" (21CFR Part 807.97). I guilation chittined, "Misoranang of router the Act may be obtained from the Oiner general mionnation on your respectional 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,
L. Mark N. Mulhern
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
TUCO Erchonia PL2000 Device Name:
Indications for Use: The TUCO Erchonia PL2000 is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number
b. Mark M. Millman
Division of General, R storative and Neurological _ rvices
510(k) Number_
X Prescription Use (Per 21 CFR 801.109)