(507 days)
Not Found
No
The summary describes a standard TENS device and does not mention any AI or ML capabilities.
Yes
Explanation: The device is described as providing "therapy" for pain associated with sore muscles, which indicates a therapeutic purpose.
No
The device description states it is a "transcutaneous electrical muscle stimulator" intended to provide "non-invasive therapy" for pain, and it lists a TENS device as its predicate. This indicates a therapeutic, rather than diagnostic, function.
No
The device description explicitly states it is a "self-contained battery operated transcutaneous electrical muscle stimulator" with "adhesive electrodes mounted on a belt," indicating it is a hardware device that delivers electrical stimulation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The NeuroTech BackTENS device is a transcutaneous electrical muscle stimulator. It applies electrical stimulation to the skin for pain relief.
- Intended Use: The intended use is to provide pain relief associated with sore and aching muscles in the lower back. This is a therapeutic application, not a diagnostic one.
The device operates externally on the body and does not involve the analysis of biological samples.
N/A
Intended Use / Indications for Use
The device is indicated for:
- Transcutaneous Electrical Nerve Stimulation (TENS), which provides the symptomatic relief and management of chronic lower back pain.
- Lumbar support.
The neurotech BACKTENS device is intended to provide to pain associated with sore and The neurotech BACKTENS device is intentiou to provins time sump and the program and in activities
Product codes (comma separated list FDA assigned to the subject device)
GZJ, GXY, and IQE
Device Description
The NeuroTech BackTENS device is a self-contained battery operated transcutaneous electrical muscle stimulator. The adhesive electrodes are mounted on a belt offering lumbar support to the user during therapy delivery.
The device is intended to provide a non-invasive therapy for over the counter sale.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower back
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparisons of electrical outputs for the two devices show similar results. They have both been designed and independently tested to the following requirements;
- IEC 60601-1:1990 Medical electrical equipment Part 1: General requirements for . safety.
- IEC 60601-2-10
- IEC 601-1-1 and appendices A1:1991,A2:1995 . IEC 601-1-2: EMC requirements
- IEC 61000-4-2:1995: Electromagnetic compatibility .
- IEC 61000-4-3:1997: Electromagnetic compatibility .
- DD ENV 50204:1996: Electromagnetic compatibility .
- EN 55011:1998: radiated emissions. .
Bio-Medical Research Ltd, (BMR), adheres to recognised and established industry practice, and all devices are subject to final performance testing.
A hazard analysis, a risk analysis and a failure mode effects analysis have been carried out for the device.
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
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
Page 1 of 2 510(k) Summary
APR 1 5 2004
Bio-Medical Research Ltd Parkmore Business Park, West Galway Ireland
| 1 | - | |
|---|---|---|
| August of the career | ||
| I | - | |
| 11 | ||
| 510 (k) Summary of Safety and Effectiveness. | |||
|---|---|---|---|
| This summary is submitted in accordance with 21 CFR 807.92 | |||
| a) | 1 | Submitted by | Bio-Medical Research Ltd |
| BMR House | |||
| Parkmore Business Park, West | |||
| Galway | |||
| Republic of Ireland | |||
| Establishment Registration Number | 8020867 | ||
| Contact Person | Michelle Sawyer | ||
| Phone | +353 91 774361 | ||
| Fax | +353 91 773302 | ||
| msawyer@des.bmr.ie | |||
| Title | Regulatory Affairs Manager | ||
| Date of Preparation | November 2002. | ||
| 2 | Trade Name of Device | NeuroTech© BackTENS & Lumbar support Type 294. | |
| Common Name | NeuroTech© BackTENS & Lumbar support. | ||
| Classification name | Transcutaneous Electrical Nerve Stimulator.(882.5810) | ||
| 3 | Identification of predicate device | NeuroTech© Smart-TENS , Type 456, Clearance ref# K961376. |
1
Description of Device 4
The NeuroTech BackTENS device is a self-contained battery operated transcutaneous electrical muscle stimulator. The adhesive electrodes are mounted on a belt offering lumbar support to the user during therapy delivery.
The device is intended to provide a non-invasive therapy for over the counter sale.
Intended Use ട
The device is indicated for:
- · Transcutaneous Electrical Nerve Stimulation (TENS), which provides the symptomatic relief and management of chronic lower back pain.
- · Lumbar support.
Technological Comparison ട
The NeuroTech BackTENS is similar to the Smart-TENS in it's delivery of the stimulation signal and has similar parameter settings. Both products utilise a LCD screen with user compliance logging.
Non- clinical Tests 7
Comparisons of electrical outputs for the two devices show similar results. They have both been designed and independently tested to the following requirements;
- IEC 60601-1:1990 Medical electrical equipment Part 1: General requirements for . safety.
- . IEC 60601-2-10
- IEC 601-1-1 and appendices A1:1991,A2:1995 . IEC 601-1-2: EMC requirements
- IEC 61000-4-2:1995: Electromagnetic compatibility .
- IEC 61000-4-3:1997: Electromagnetic compatibility .
- DD ENV 50204:1996: Electromagnetic compatibility .
- EN 55011:1998: radiated emissions. .
Bio-Medical Research Ltd, (BMR), adheres to recognised and established industry practice, and all devices are subject to final performance testing.
A hazard analysis, a risk analysis and a failure mode effects analysis have been carried out for the device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol consisting of three curved lines, resembling a caduceus or a representation of human services. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 2004
Carol O'Donnell, Ph.D. Clinical and Regulatory Affairs Manager Bio-Medical Research Limited BMR House Parkmore Business Park West Galway Ireland
Re: K023916
Trade Name: NeuroTech® Back TENS and Lumbar Support, Type 294 Regulation Number: 21 CFR 882.5890, 21 CFR 882.1320, and 21 CFR 890.3490 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief, Cutaneous electrode, and Truncal orthosis
Regulatory Class: II Product Code: GZJ, GXY, and IQE Dated: January 8, 2004 Received: January 16, 2004
Dear Dr. O'Donnell:
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 complics 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.
3
Page 2 - Carol O'Donnell, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and w your finding of substantial equivalence of your device to a legally prematted 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 (301) 594-4659. 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 may be obtained 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 vours,
Sincerely yours,
Mark A. Mcllussen
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
4
Indications for Use
510(k) Number (if known):K023916
neurotech BACKTENS & Lumbar Support Device, type 294 Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The neurotech BACKTENS device is intended to provide to pain associated with sore and The neurotech BACKTENS device is intentiou to provins time sump and the program and in activities
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Mark N. Milham
eral, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K023916