(180 days)
Not Found
No
The document describes a device that delivers TENS and LLLT based on pre-set parameters and does not mention any adaptive or learning capabilities.
Yes
The device description clearly states, "The Neurolumen is a medical therapy device." Additionally, its intended use involves temporary relief of various types of pain and muscle issues, which are therapeutic applications.
No
The device is described as a "medical therapy device" that delivers TENS and LLLT for pain relief and promotion of muscle relaxation and increased blood circulation, which are therapeutic functions, not diagnostic ones.
No
The device description clearly outlines hardware components including a control unit, wraps containing laser diodes, LEDs, and TENS gel pads, and an internal battery with a charger. This indicates it is a physical medical device, not software-only.
Based on the provided information, the Neurolumen is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Neurolumen is a therapeutic device that applies energy (TENS and LLLT) directly to the patient's body (limbs) for pain relief and other physical effects. It does not analyze any biological samples.
The description clearly states its function is to deliver therapy to the patient's limbs, not to perform tests on samples.
N/A
Intended Use / Indications for Use
The Neurolumen is indicated 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 Neurolumen is also indicated for 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
The Neurolumen is a medical therapy device that delivers Transcutaneous Electrical Nerve Stimulation (TENS) and Low Level Laser Therapy (LLLT) to a patient's limbs.
The Neurolumen consists of a control unit and six wraps. Each wrap contains two laser diodes, 4 light emitting diodes, and one or two TENS gel pads. After applying the wraps to the feet, ankles, and legs, the control unit is able to provide up to 30 minutes of therapy on a single charge of the internal lithium-ion battery. A charger is provided for recharging the internal battery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limbs, feet, ankles, and legs
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)
The laser diodes were tested on three subjects to demonstrate that the device is able to raise the skin temperature between 40-45 degrees C for at least 10 minutes. The testing results confirmed that the unit is capable of raising and maintaining these temperatures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K082223, K061614, K071445, K081141
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 21, 2015
Neurolumen, LLC % Mr. Andy Thompson Systec Engineering, LLC P.O. Box 1123 Euless. Texas 76039
Re: K142025
Trade/Device Name: Neurolumen PN-1000 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY, GZJ Dated: December 17, 2014 Received: December 18, 2014
Dear Mr. Thompson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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 (reporting of medical
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142025
Device Name
Neurolumen PN-1000
Indications for Use (Describe)
The Neurolumen is indicated 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 Neurolumen is also indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-traumatic acute pain.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/0 description: The image shows the logo for SYSTEC Innovative Technologies LLC. The logo features the word "SYSTEC" in large, bold letters, with the words "INNOVATIVE TECHNOLOGIES LLC" underneath in a smaller font. To the right of the text is a circular graphic with a star-like design inside.
Section C
510(k) Summary
12/12/2014
Contact Information:
| 510(k) Owner | 510(k) Submitter |
|---|---|
| Neurolumen, LLC | Systec Engineering, LLC |
| 9636 N. May Ave, Suite 230 | dba Systec Innovative Technologies, LLC |
| Oklahoma City, OK 73120 | PO Box 1123 |
| 405-463-6525 phone | Euless, TX 76040 |
| 405-463-6528 fax | 817-864-9197 phone |
| Doug Durning | 817-684-1019 fax |
| doug@neurolumen.com | Andy Thompson |
| andy@systeceng.com |
Device Identification:
Trade Name: Neurolumen PN-1000 Requiatory Class: II Requlation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Product Code: ILY, GZJ
Claiming Equivalence to:
Trade Name: NeurolumenPN 510(k) Number: K082223 Regulatory Class: II Regulation Number: 21 CFR 890.5500 Requlation Name: Infrared Lamp Product Code: ILY, GZJ
Trade Name: TerraQuant MQ2000 and HandyRx Laser MQ2007 510(k) Number: K061614 Regulatory Class: II Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Product Code: ILY, GEX
Trade Name: TerraQuant MQ2000 with TQ-1TENS
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Image /page/4/Picture/0 description: The image shows the logo for SYSTEC Innovative Technologies LLC. The logo is composed of the company name in bold, stylized font, with the words "Innovative Technologies LLC" in a smaller font size below. To the right of the company name is a circular graphic containing a five-pointed star with small circles at the end of each point.
510(k) Number: K071445 Regulatory Class: II Regulation Number: 21 CFR 890.5500 Requlation Name: Infrared Lamp Product Code: ILY, GEX, GZJ
Trade Name: ComboCare 2000 510(k) Number: K081141 Regulatory Class: II Regulation Number: 21 CFR 890.5500 Regulation Name: Transcutaneous electrical nerve stimulation for pain relief. Product Code: GZJ, NHN, ISA
Device Description:
The Neurolumen is a medical therapy device that delivers Transcutaneous Electrical Nerve Stimulation (TENS) and Low Level Laser Therapy (LLLT) to a patient's limbs.
The Neurolumen consists of a control unit and six wraps. Each wrap contains two laser diodes, 4 light emitting diodes, and one or two TENS gel pads. After applying the wraps to the feet, ankles, and legs, the control unit is able to provide up to 30 minutes of therapy on a single charge of the internal lithium-ion battery. A charger is provided for recharging the internal battery.
Image /page/4/Picture/7 description: The image shows a collection of electronic components and accessories. There are two black heating pads, each with a power cord. A digital display unit with multiple buttons is also present, along with a power adapter. The components appear to be part of a heating system or electronic device setup.
PN-1000 Components
Image /page/4/Picture/9 description: In the image, a person is lying down with a device attached to their leg. The device has a digital display and several buttons with arrows pointing in different directions. The person's hands are holding the device, and there are tubes connecting the device to the leg. The device appears to be a medical device used for therapy or treatment.
PN-1000 Typical Usage
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Image /page/5/Picture/0 description: The image shows the logo for SYSTEC Innovative Technologies LLC. The logo is in black and white and features the word "SYSTEC" in large, bold letters. Below that is "INNOVATIVE TECHNOLOGIES LLC" in smaller letters. To the right of the text is a circular design with a star inside.
Image /page/5/Picture/2 description: The image shows a black device with two textured rectangular areas on top. A cable is connected to the device, and a separate textured rectangular piece is placed next to it. The device appears to be some sort of electronic equipment, possibly a charger or adapter, with the textured areas potentially serving as contact points or sensors.
PN-1000 Leg Wrap with Gel Pad
Image /page/5/Picture/4 description: The image shows two electronic devices connected by a cable. Both devices appear to be rectangular with a screen or display area in the center. The device on the left has a slightly larger base or bottom section compared to the one on the right. The cable connecting the two devices is black and has a connector on one end.
PN-1000 Foot/Ankle Wrap
| Unit | |
|---|---|
| Model | Neurolumen PN-1000 |
| Part Number | 0904000-00 |
| Battery | Lithium-Ion 3.6V |
| Charger | 220/110 VAC, 50/60Hz input |
| 9VDC 1.5A output | |
| Laser Diodes | |
| Quantity per wrap | 2 |
| Wavelength | 808nm |
| Output Power | 1mW |
| LEDs, Red | |
| Quantity per wrap | 2 |
| Wavelength | 660nm |
| Output Power | 90μW |
| LEDs, IR | |
| Quantity per wrap | 2 |
| Wavelength | 940nm |
| Output Power | 22μW |
| TENS (Load Impedance 500-550 ohms) | |
| Frequency | 2 Hz |
| Output Current | 100mA max |
| Pulse Voltage | 75VDC max |
| Pulse width | 100us biphasic |
Intended Use:
The Neurolumen is indicated 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.
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Image /page/6/Picture/0 description: The image shows the logo for SYSTEC Innovative Technologies LLC. The logo features the word "SYSTEC" in large, bold, black letters. Below that, the words "INNOVATIVE TECHNOLOGIES LLC" are written in a smaller font. To the right of the text is a black circle with a white star inside.
The Neurolumen is also indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-traumatic acute pain.
There are no changes to the intended use from the predicate device.
Comparison of technological characteristics:
| Characteristic | Predicate Device | Neurolumen PN-1000 |
|---|---|---|
| Control circuit | K082223: Digital circuit | Microcontroller. |
| A 8-bit microcontroller was | ||
| added to drive a newly | ||
| added user interface, | ||
| monitor the device | ||
| functions, and generate the | ||
| TENS pulse timing. | ||
| Liquid Crystal Display | K082223: Not present | |
| K071445: Present | Added to display TENS | |
| intensities, battery status, | ||
| and therapy countdown | ||
| timer. | ||
| Firmware | K082223: Not present | |
| K071445: Present | Added for microcontroller. | |
| Firmware developed per the | ||
| FDA guidance document on | ||
| medical devices containing | ||
| software. | ||
| Battery | K082223: 4 AA NiMH | |
| batteries | 1 Li-Ion battery pack added | |
| for improved charge density | ||
| and cycle life. | ||
| TENS Pulse | K082223: | |
| Pulse width: 100us biphasic. | ||
| Frequency: 2 Hz repetition | ||
| rate. | ||
| Current: 100mA max. | Identical | |
| Laser Classification | K082223: Not present | |
| K061614: IIIa | Laser classification testing | |
| to IEC 60825-1 rated laser | ||
| and LED output at class 3R | ||
| (IIIa). Equivalent to other | ||
| predicate devices cleared | ||
| as non-heating lamps. | ||
| Laser Diodes | K082223: Not present | |
| K061614: 905nm | ||
| K071445: 905nm | 808nm | |
| Red LEDs | K082223: 660nm | 660nm |
| K061614: 680nm | ||
| K081141: 640nm | ||
| K071445: 660nm | ||
| IR LEDs | K082223: 905nm | 940nm |
| K061614: 840nm | ||
| K081141: 870nm | ||
| K071445: 875nm |
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Image /page/7/Picture/0 description: The image shows the logo for SYSTEC Innovative Technologies LLC. The logo is in black and white. To the right of the text is a circle with a star inside.
The determination of substantial equivalence is derived from the fact that the new device is based on the predicate device with improvements to the user interface and laser diode. It contains the same basic construction in the control unit and wrap assemblies, contains the identical TENS output waveform, and contains the same basic types of LED/laser diode outputs as predicate devices.
The New Device has been fully tested to national and international safety standards for medical devices, including IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-10, and IEC 60825-1.
Device Testing Results
The laser diodes were tested on three subjects to demonstrate that the device is able to raise the skin temperature between 40-45 degrees C for at least 10 minutes. The testing results confirmed that the unit is capable of raising and maintaining these temperatures.