(176 days)
Not Found
No
The document describes a standard TENS device with microprocessor control and an LCD display, and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is a Transcutaneous Electrical Nerve Stimulator (TENS) intended for "temporary relief of pain associated with sore and aching muscles," which is a therapeutic purpose.
No
The device description clearly states its intended use is to "relieve pain associated with sore and aching muscles," which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "portable and microprocessor-controlled Santamedical Pulse Stimulator" that "delivers a gentle electrical pulse through two channels with four attachment pads and shows graphic information about mode style, intensity and time remaining on a LCD based display which is incorporated within the device body." This indicates the device includes physical hardware components beyond just software.
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 temporary relief of pain associated with sore and aching muscles. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS). TENS devices deliver electrical pulses to the body for pain relief. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Product codes
NUH, NGX
Device Description
The Santamedical Pulse Stimulator, a Transcutaneous Electrical Nerve Stimulator (TENS), is for overthe-counter use and for home use, which is intended to relieve pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg, due to strain from exercise or normal household and work activities. The portable and microprocessor-controlled Santamedical Pulse Stimulator delivers a gentle electrical pulse through two channels with four attachment pads and shows graphic information about mode style, intensity and time remaining on a LCD based display which is incorporated within the device body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use; home 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)
Non-clinical tests were performed on the proposed Santamedical Pulse Stimulator in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, electromagnetic compatibility, and particular requirements for the safety of nerve and muscle stimulators:
- (a) IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance".
- (b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
In addition to the compliance of voluntary standards, the electrodes also meet the safety requirement, and the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K131933
Exhibit 013 Revised 510(k) Summary
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter's Information
Submitter: Gurin Products, LLC Address: 2522 Chambers Road, Suite 100, Tustin, CA 92780 Contact Person: Sanjay Gupta Tel: 888-666-1557 Email: iroams@earthlink.net Date of Preparation: 06/24/2013
2. Proposed Device
Trade Name: Santamedical Pulse Stimulator Common Name: Transcutaneous electrical nerve stimulator Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter (OTC) Regulation Description: Transcutaneous electrical nerve stimulator for pain relief Regulation Medical Specialty: Neurology Review Panel: Neurology Product Code: NUH, NGX Regulation Number: 21 CFR 882.5890 Use: Over-The-Counter Device Class: II
3. Predicate device
Prospera OTC TENS Electronic Pulse Massager 510(k) Number: K122744 Submitter: Prospera Corporation
4. Description of Proposed Device
The Santamedical Pulse Stimulator, a Transcutaneous Electrical Nerve Stimulator (TENS), is for overthe-counter use and for home use, which is intended to relieve pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg, due to strain from exercise or normal household and work activities. The portable and microprocessor-controlled Santamedical Pulse Stimulator delivers a gentle electrical pulse through two channels with four attachment pads and shows graphic information about mode style, intensity and time remaining on a LCD based display which is incorporated within the device body.
5. Indications for Use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
6. Technological Characteristics
Both the proposed and predicate devices have the identical technological characteristics, as shown in Table 1 below.
1
| Proposed Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K131933 | K122744 |
| Device Name | Santamedical Pulse Stimulator | Prospera OTC TENS Electronic |
| Pulse Massager | ||
| Intended Use | To be used for temporary relief | |
| of pain associated with sore | ||
| and aching muscles in the | ||
| shoulder, waist, back, neck, | ||
| upper extremities (arm), and | ||
| lower extremities (leg) due to | ||
| strain from exercise or normal | ||
| household work activities. | To be used for temporary relief | |
| of pain associated with sore and | ||
| aching muscles in the shoulder, | ||
| waist, back, neck, upper | ||
| extremities (arm), and lower | ||
| extremities (leg) due to strain | ||
| from exercise or normal | ||
| household work activities. | ||
| Power Source | Battery | Battery |
| Number of Output Channels | 2 | 2 |
| Automatic Overload Trip | No | No |
| Automatic Over Current Trip | No | No |
| Automatic No-Load Trip | No | No |
| Automatic Shut Off | Yes | Yes |
| User Override Control | Yes | Yes |
| Indicator Display | Yes | Yes |
| Waveform | Monophasic, pulsed | Monophasic, pulsed |
| Frequency | 1-100 Hz | 1-100 Hz |
| Compliance with Voluntary | ||
| Standards | IEC60601-1, IEC60601-1-2 | IEC60601-1, IEC60601-1-2 |
| Compliance with 21 CFR 898 | Yes | Yes |
| Housing Materials & | ||
| Construction | ABS Plastic | ABS Plastic |
Tablo 1 Charactoristic com parison hetween the proposed device and predicate device
7. Non-Clinical Tests Performed for Determination of Substantial Equivalence
Compliance to applicable voluntary standards includes IEC 60601-1-2. Non-clinical tests were performed on the proposed Santamedical Pulse Stimulator in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, electromagnetic compatibility, and particular requirements for the safety of nerve and muscle stimulators:
- (a) IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance".
- (b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
In addition to the compliance of voluntary standards, the electrodes also meet the safety requirement, and the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
8. Conclusion
The proposed device is substantially equivalent to the predicate device. Therefore, the proposed Santamedical Pulse Stimulator is as safe, as effective, and performs as well as the foregoing identified OTC predicate devices which have been legally marketed in the United States.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2013
Gurin Products, LLC Sanjay Gupta President 2522 Chambers Road, Suite 100 Tustin, CA 92780
Re: K131933
Trade/Device Name: Santamedical Pulse Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: November 25, 2013 Received: December 3, 2013
Dear Mr. Gupta:
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
3
Page 2 - Mr. Sanjay Gupta
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Joyce M. Whang -S
for
Carlos L. Peña, PhD Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K131933
Device Name: Santamedical Pulse Stimulator
Indications For Use:
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Prescription Use (Part 21 CFR 801 Subpart D)
and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of
AND/OR
Over-The-Counter Use _ X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
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