(238 days)
Not Found
No
The description focuses on standard electrical stimulation parameters and controls, with no mention of AI or ML algorithms for pain management or parameter adjustment.
Yes
The device is intended for pain relief and is described as an electrical nerve stimulator for treating pain through electrical currents applied to the skin.
No
This device is a TENS unit, which is used for pain relief by stimulating nerves with electrical impulses. Its function is therapeutic, not diagnostic.
No
The device description explicitly states it is a "battery operated pulse generator" and mentions "electronics," "output channels," "electrodes," "controls/switches," and a "liquid crystal display," all of which are hardware components.
Based on the provided text, the EV-803 Digital TENS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "pain relief by applying an electrical current to electrodes on a patient's skin to treat pain." This is a therapeutic application, not a diagnostic one.
- Device Description: The description details how the device generates electrical impulses and applies them to the body through electrodes. This is consistent with a TENS device used for pain management.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
Therefore, the EV-803 Digital TENS is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
EV-803 Digital TENS is an electrical nerve stimulator intended for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain.
EV-803 Digital TENS is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain.
In particular, this device is indicated for use for:
- Symptomatic relief and management of chronic (long term) intractable pain
- Adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
Product codes
GZJ
Device Description
EV-803 Digital Tens is a battery operated pulse generator that sends electrical impulses through electrodes to the body and reach the nerves causing pain. The device is provided with two controllable output channels, each independent of each other. An electrode pair can be connected to each output channel.
The electronics of the EVERYWAY EV-803 DIGITAL TENS create electrical impulses whose intensity, duration, number per second and modulation may be altered with the controls/switches. Press buttons are very easy to use and the large liquid crystal display showing the exact mode and values of parameters are very convenient for patients.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
TransAmerica Medical Systems, 510k #K010782
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
OCT 31 2002
510(k) Summary
16020749 As Required by 21 section 807.92 ( c )
1-Submitter Name: Everyway Medical Instruments Co., Ltd
2-Address: 3FL.. No. 5, Lane 155, Sec. 3, PeiShen Rd., Shen Keng Hsiang
Taipei Hsien Taiwan, R.O.C.
886-2-2662-0038
3-Phone:
4-Fax: 886-2664-5566
5-Contact Person: Mr Robert Tu (General Manager)
6-Date summary prepared: February 27th, 2002
7- Official Correspondent: Mansour Consulting
8- Address:
1308 Morningside Park Dr Alpharetta, GA 30022 USA
9- Phone: 10- Fax:
- (678) 908-8180 (425) 795-9341
Jay Mansour, president 11- Contact person:
12-Device Trade or Proprietary Name: EV-803 Digital TENS
13-Device Common or usual name: Stimulator, Nerve, Transcutaneous, for pain relief
- 14-Device Classification Name: Stimulator, Nerve, Transcutaneous, for pain relief
15-Substantial Equivalency is claimed against the following device:
TransAmerica Medical Systems, 510k #K010782 (refer to Appendix 2 for FDA website printout)
This notification for EV-803 is of the ABBREVIATED type as per the declaration of conformitv included in this summary
16-Description of the Device: EV-803 Digital Tens is a battery operated pulse generator that sends electrical impulses through electrodes to the body and reach the nerves causing pain. The device is provided with two controllable output channels, each independent of each other. An electrode pair can be connected to each output channel.
The electronics of the EVERYWAY EV-803 DIGITAL TENS create electrical impulses whose intensity, duration, number per second and modulation may be altered with the controls/switches. Press buttons are very easy to use and the large liquid crystal display showing the exact mode and values of parameters are very convenient for patients.
17-Intended use of the device: (Indications for use typed on a separate FDA form)
EV-803 Digital TENS is an electrical nerve stimulator intended for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain
18-Safety and effectiveness of the device:
This device is safe and effective as the predicate device Transamerica Digital EMS. Indeed, it is identical. The same device which was cleared by 510k #K010782 for the distributor TransAmerica Medical Systems is submitted here for the original manufacturer in Taiwan EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
Refer to the tabulated comparison (Paragraph 19 below)
19-Summary comparing technological characteristics with other predicate device:
1
| FDA file reference number | 510k #K010782 |
|---|---|
| Attachments inside notification submission file | 510k summary print out |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Identical |
| Materials | Identical |
| Performance | Identical |
| Sterility | Identical |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical |
| Compatibility with environment and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| Thermal safety | Identical |
| Radiation safety | Identical |
:
2
3FL., No.5, Lane 155, Sec. 3, PeiShen Rd., Shen Keng Hsiang, Taipei Hsien, Taiwan, R.O.C.
Tel: 886-2-2662-0038 Fax: 886-2-2664-5566 E-mail: everywy@ms2.hinet.net
DECLARATION OF CONFORMITY
This is to declare and confirm that Everyway Medical Instruments Co., Ltd. conforms in its manufacturing of Transcutaneous Electrical
Nerve Stimulators EV-803 Digital TENS to the following recognized standards:
Standards met and standards tested against
| Inapplicable requirements or deviations | Name and address of any test laboratory or certification body involved in determining the conformance of the device with the standard and reference to any accreditations of those organizations | |
|---|---|---|
| Identification of any way(s) in which the standard was adapted for the application of the device, i.e., identification of an alternative series of tests that were performed | ||
| Specification of any deviations from each applicable standard | ||
| Specification of the differences that may exist between the tested device and the device to be marketed and justification of the test results |
| Supervision of product and design: | |
|---|---|
| QSR (FDA's Quality System Requirements) | For QSR: Not applicable |
| DIN EN ISO 9002/08.1994 | For ISO 9002: 1994, EN 46002, ISO 13488 and CE Mark: TUV Rheinland Product Safety GmbH- Am Grauen Stein -D-51105 Koln. TUV Rheinland Product Safety GmbH- Am Grauen Stein-D-51105 Koln. |
| DIN EN 46002/09.1996 EE Directive 93/42 (CE Mark) | |
| ISO 13488/12.1996 | |
| Technical standards: | N/A. |
| EN 60601-1:1990+A1:1993+A2:1995 | |
| EN60601-1-2:1993 |
| Name, Signature and position | Robert Tu/ General Manager |
|---|---|
| Date | 02/27/2002 |
011,00 STREMUATSNI JAOIG3M YAWYA3V3 2458333
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines forming a profile. The figure is positioned to the right of the department's name, which is arranged in a circular pattern around the logo.
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
OCT 3 1 2002
Mr. Jay Mansour Representing Everyway Medical Instruments Co., Ltd. Mansour Consulting, L.L.C. 1308 Morningside Park Drive Alpharetta, Georgia 30022
K020749 Re:
Trade/Device Name: EV-803 Digital TENS Regulation Number: 21 CFR 882.5890 Regulation Name: TENS Device for Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: July 26, 2002 Received: August 1, 2002
Dear Mr. Mansour:
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 vour 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
4
Page 2 - Mr. Jay. Mansour
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) 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) 594-4648. 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
K. Mark-N-Millican
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
5
Page 1 of
KO20749 510 (k) NUMBER (IF KNOWN)
DEVICE NAME: Digital Transcutaneous Electrical Nerve Stimulator (EV-803 Digital TENS) INDICATIONS FOR USE:
EV-803 Digital TENS is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain.
In particular, this device is indicated for use for:
- Symptomatic relief and management of chronic (long term) intractable pain
- Adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
(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 001.109) ાર
Over-The-Counter-Use (Optional Format 1-2-9
0.03
for Mark n Millican
(Division Sign-Off) Division of General. Restorative and Neurological Devices
510(k) Number K020749