K Number
K014020
Device Name
NT MEDITENS PLUS, TYPE 290
Date Cleared
2002-07-11

(217 days)

Product Code
Regulation Number
882.5890
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The symptomatic relief and management of chronic intractable pain. It is also an adjunctive treatment in the management of post-surgical and posttraumatic pain. The device has no curative value and should only be used in conjunction with Medical supervision.
Device Description
The MediTENS PLUS is a portable two-channel battery operated transcutancous clectrical nerve stimulator. The device is intended for prescriptive use per 21 € FR 801.109. It comprises of the device and two colour differentiated lead wires. which connect to four skin surface electrodes. The device is powered by a 9-volt (tvpc 6f-22) battery located in a compartment to the rear of the device with a detachable battery cover. The device is supplied with a set of adhesive electrodes, a carrying case, the user instruction manual and a battery.
More Information

Rehabilicare Promax

Not Found

No
The description focuses on the device's function as a TENS unit and its electrical stimulation capabilities, with no mention of AI or ML features.

Yes
The device is indicated for symptomatic relief and management of chronic intractable pain, as well as an adjunctive treatment for post-surgical and posttraumatic pain, which are therapeutic uses.

No

The device is described as a "transcutaneous electrical nerve stimulator" for symptomatic relief and pain management, which are therapeutic functions, not diagnostic.

No

The device description explicitly states it is a "portable two-channel battery operated transcutaneous electrical nerve stimulator" and includes physical components like lead wires, electrodes, and a battery. This indicates it is a hardware device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the symptomatic relief and management of pain through electrical nerve stimulation. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Description: The description details a transcutaneous electrical nerve stimulator (TENS) device that applies electrical stimulation to the skin. This is a physical therapy modality, not a device for analyzing biological samples.
  • Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.

The device is clearly described as a therapeutic device for pain management.

N/A

Intended Use / Indications for Use

The MediTENS PLUS is intended for use with a wide range of patients. It is intended to effect non-invasive stimulation therapy for the symptomatic relief of chronic pain and relaxation of musele spasm

The MediTENS PLUS is indicated for:

  • The symptomatic relief and management of chronic intractable pain. It is also an adjunctive treatment in the management of post-surgical and posttraumatic pain. The device has no curative value and should only be used in conjunction with Medical supervision.

Product codes (comma separated list FDA assigned to the subject device)

GZJ

Device Description

The MediTENS PLUS is a portable two-channel battery operated transcutancous clectrical nerve stimulator. The device is intended for prescriptive use per 21 € FR 801.109.

It comprises of the device and two colour differentiated lead wires. which connect to four skin surface electrodes.

The device is powered by a 9-volt (tvpc 6f-22) battery located in a compartment to the rear of the device with a detachable battery cover.

The device is supplied with a set of adhesive electrodes, a carrying case, the user instruction manual and a battery.

Built in safety features are clearly outlined in this submission. which greatly reduce the possibility of mis-use.

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

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 MediTENS PLUS was designed to. and has been independently tested to IEC 601-1: 1998 +A1: 1991+ A2: 1995. IEC 601-2-10:1987. IEC 601-1-2:1993. Bio-Medical Research LTD adheres to recognised and established industry practices and all devices are subject to final performance testing.

A Hazard analysis. risk analysis and 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.

Rehabilicare Promax

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

JUL 11 2002

10140200

510(k) Summary of safety and effectiveness.

This summary is submitted in accordance with 21 CFR 807.92

| a) Submitted by | Bio-Medical Research Ltd
BMR House
Parkmore Business Park. West
Galway
Republic of Ireland. |
|----------------------------------------|---------------------------------------------------------------------------------------------------------|
| Contact person | Michelle Sawyer |
| Phone | +353 91 774361 |
| Fax | +353 91 774302 |
| e-mail | msawyer@des.bmr.ie |
| Title | Regulatory Affairs Specialist- |
| Date of preparation | 04 December 2001 |
| Trade name of Device | NI MediTENS PLUS |
| Common name | |
| Classification name | Transcutaneous electrical nerve
stimulator |
| Identification of predicate
Device. | Rehabilicare Promax |

Description of the device.

The MediTENS PLUS is a portable two-channel battery operated transcutancous clectrical nerve stimulator. The device is intended for prescriptive use per 21 € FR 801.109.

It comprises of the device and two colour differentiated lead wires. which connect to four skin surface electrodes.

The device is powered by a 9-volt (tvpc 6f-22) battery located in a compartment to the rear of the device with a detachable battery cover.

The device is supplied with a set of adhesive electrodes, a carrying case, the user instruction manual and a battery.

Built in safety features are clearly outlined in this submission. which greatly reduce the possibility of mis-use.

Page 1 of 2

PM

Q II

1

Intended use.

The MediTENS PLUS is intended for use with a wide range of patients. It is intended to effect non-invasive stimulation therapy for the symptomatic relief of chronic pain and relaxation of musele spasm

Fechnological comparison

The MediTENS PLUS is similar to the Promax device in that it delivers a stimulation signal. which is almost identical with similar parameter settings.

Non-clinical tests.

The MediTENS PLUS was designed to. and has been independently tested to IEC 601-1: 1998 +A1: 1991+ A2: 1995. IEC 601-2-10:1987. IEC 601-1-2:1993. Bio-Medical Research LTD adheres to recognised and established industry practices and all devices are subject to final performance testing.

A Hazard analysis. risk analysis and failure mode effects analysis have been carried out for the device.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 symbol that resembles three human profiles facing to the right, with flowing lines connecting them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

... 11 2002

Mrs. Michelle Sawyer Bio-Medical Research Ltd. BMR House Parkmore Business Park West Galway, Ireland

Re: K014020

Trade/Device Name: Neurotech MediTENS PLUS, Type 290 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: April 10, 2002 Received: April 15, 2002

Dear Mrs. Sawyer:

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. Ilsting 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. This letter will allow you to begin marketing your device as described in your Section 510(k)

3

Page 2 - Mrs. Sawyer

premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,

Stipt Clwodu

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 statement

. 510(k) number (if known):

Device Name:

Sponsor Name:

Not available

K014020

NeuroTech MediTENS PLUS. Type 290.

Bio-Medical Research Ltd. (NeuroTech is a division of Bio-Medical Research Ltd.)

Indications for use.

The MediTENS PLUS is indicated for:

  • The symptomatic relief and management of chronic intractable pain. It is also an adjunctive treatment in the management of post-surgical and posttraumatic pain. The device has no curative value and should only be used in conjunction with Medical supervision.
    Do Not Write Below This Line -Continue on Another Page if Needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use

Over -The -Counter- Use

er- Use

Styph Plurdy
Division S:

(Division Sign-Off) Division of General, Restorative The ablon of General, Resto

510(k) Number_KO14 oz o