(90 days)
Not Found
No
The summary describes a standard TENS device with no mention of AI or ML capabilities in its intended use, description, or performance studies. The clinical testing section explicitly states there are no new or innovative aspects introduced.
Yes
The device is described as being used for the "symptomatic relief and management of chronic intractable pain" and "as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain," which are therapeutic applications.
No
The device is described as providing symptomatic relief and management of pain by blocking pain signals, which is a therapeutic function, not a diagnostic one. It does not identify disease or assess health conditions.
No
The device description explicitly states that the device transmits electrical pulses through the skin, which requires hardware components (electrodes, power source, circuitry) and is not solely software. The performance studies also reference standards for electrical medical equipment (IEC 60601-1, IEC 601-1) and a standard for TENS devices (AAMI/ANSI NS-4), further indicating a hardware component.
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, which is a therapeutic application, not a diagnostic one.
- Device Description: The device description explains that it transmits electrical pulses to block pain signals, which is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The V TENS Plus is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
Product codes
GZJ
Device Description
The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of the pain signal travelling to the brain.
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
Not Applicable as there are no new or innovative aspects that have been introduced.
Key Metrics
Not Found
Predicate Device(s)
FUJI TENS 804SIII (K893874)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
10 510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _KOZ 273
10.1 Submitter's Identification:
NOV 1 4 2002
Body Clock Health Care Ltd 108 George Lane South Woodford London E18 1AD United Kingdom
+44 (0)20 8532 9551 Tel: +44 (0)20 8532 9551 Fax:
| Contact: | Jonathan Bash |
|---|---|
| Date Prepared: | August 09th 2002 |
10.2 Name of Device:
Proprietary Name: V-TENS Plus
Common or Usual Name: TENS unit (Transcutaneous Electrical Nerve Stimulator)
Classification Name:
Stimulator, Nerve, Transcutaneous, For Pain Relief.
10.3 Predicate Device Information:
The V-TENS Plus is equivalent to the FUJI TENS 804SIII (K893874)
10.4 Device Description:
The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of the pain signal travelling to the brain.
10.5 Intended Use:
TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
1
10.6 Technological Comparison to Predicate Device:
The V-TENS Plus has technological characteristics that are substantially equivalent to the predicate device. It differs slightly from the Fuji TENS 804SIII. There is only one dial for pulse rate adjustment. This means that both the left and the right hand channel are controlled by one dial as opposed to having two independent controls. Secondly it is capable of Pulse Width Adjustment.
Unlike the 804SIII, the V-TENS Plus does not have modulation mode. However, it does have jack plug at the top of the unit for a booster button. Once inserted the user sets the mode to burst. If the user depresses the booster button, the unit instantly changes to constant mode.
The unit uses "shrouded patient cable connector's to comply with the FDA's Final Rule "Medical Devices: Establishment of Performance Standards for Electrode Lead Wires and Patient Cables."
10.7 Non-clinical Testing:
All required sections of the AAMI/ANSI NS-4 Standard were met. All units pass the required IEC 60601-1:1990 + a1:1993 + A2: 1995 standards. All units pass the IEC 601-1:1988 + a1:1991 + A2:1995 standards.
10.8 Clinical Testing:
Not Applicable as there are no new or innovative aspects that have been introduced.
10.9 Conclusions:
The V-TENS Plus has the same intended use and similar technical characteristics as the FUJI TENS 804SIII (K893874).
The information supplied in this 510(k) illustrate that the device does not pose any new questions of safety and effectiveness. The V-TENS Plus is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
ood and Drug Administratio 200 Corporate Boulevard Rockville MD 20850
Body Clock Health Care Ltd Jonathan Bash 108 George Lane, South Woodford London E18 1AD United Kingdom
NOV 14 2002
Re: K022731
Trade/Device Name: V TENS Plus Regulation Number: 892.5890 Regulation Name: Transcutaneous electrical nerve stimulator Regulatory Class: Class II Product Code: GZJ Dated: August 9, 2002 Received: August 16, 2002
Dear Mr. Bash:
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. Iisting 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 setforth 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 – Mr. Jonathan Bash
This letter will allow you to begin marketing your device as described in your Section 510(k) 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) 594-4659. 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" (21 CFR 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.
Sincerely yours,
L. Mark N. Mcllhanan
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
Statement of Indications For Use 8
510 (k) Number (if known): K022731
V TENS Plus Device Namels:
Indications For Use:
The V TENS Plus is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801.109)
(Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number
-Mark-St-Millerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number.