(258 days)
Not Found
Not Found
No
The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and the device description and intended use do not suggest the use of such technologies.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is indicated for the temporary relief of various types of pain and to promote relaxation and blood circulation, which are therapeutic purposes.
No
The description states the device is used 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" and "symptomatic relief and management of chronic intractable pain and adjunctive treatment for post-surgical and post-traumatic acute pain." These are therapeutic uses, not diagnostic.
No
The device description mentions "NeurolumenPN System, Model 1000" and the intended use describes "LED Stimulation for therapeutic heat" and "TENS Stimulation". These descriptions strongly suggest the device includes hardware components for delivering LED and TENS stimulation, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes therapeutic applications (pain relief, muscle relaxation, increased blood circulation) using LED and TENS stimulation. These are treatments applied to the body, not tests performed on samples taken from the body.
- Device Description: The description mentions a "System, Model 1000," which aligns with a physical therapy or pain management device, not a diagnostic test kit or instrument.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is therapeutic, not diagnostic.
N/A
Intended Use / Indications for Use
LED Stimulation for therapeutic heat
The NeurolumenPN 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
TENS Stimulation
The symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-traumatic acute pain.
Product codes
ILY, GZJ
Device Description
Not Found
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
Prescription Use
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the edge. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Neurolumen % Ms. Shelly Henry President 11108 Ashford Drive Yukon, Oklahoma 73099
Re: K082223
Trade/Device Name: NeurolumenPN Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY, GZJ Dated: April 8, 2009 Received: April 9, 2009
Dear Ms. Henry:
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 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.
APR 2 1 2009
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 - Ms. Shelly Henry
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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
Mark N. Meller
Mark N. Mel rson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 16 of 17
3/7/2009 K08223 Neurolumen PN System, Model 1000
Indications for Use
510(k) Number (if known): K082223
Device Name: NeurolumenPN
Indications for Use:
LED Stimulation for therapeutic heat
The NeurolumenPN 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
TENS Stimulation
, l
The symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-traumatic acute pain.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil. A.P. Andhra for mxm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices ।
510(k) Number K082223
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