(299 days)
Not Found
No
The device description details a standard TENS unit with selectable pre-programmed waveforms and adjustable intensity and time. There is no mention of AI, ML, or any adaptive or learning capabilities. The performance studies focus on functional performance, electrical safety, and software verification according to FDA guidance, not on the performance of an AI/ML algorithm.
Yes
The device is described as an "OTC TENS unit" for "relief of pain associated with sore or aching muscles," which falls under the definition of a therapeutic device designed to treat a medical condition.
No
Explanation: The device is intended for pain relief through electrical stimulation, not for identifying or diagnosing a medical condition.
No
The device description explicitly details hardware components including batteries, a belt with electrodes and wires, and a control unit. While software verification is mentioned, the device is clearly a physical TENS unit with integrated software, not a standalone software application.
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 relief of pain associated with sore or aching muscles of the lower back. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a TENS (Transcutaneous Electrical Nerve Stimulation) unit, which is a device that delivers electrical impulses to the body for pain relief. This is a physical therapy modality, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device operates externally on the body for pain relief.
N/A
Intended Use / Indications for Use
The Savia OTC TENS Device, Model EM-38 is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
The intended use of the SAVIA OTC TENS unit Model EM-38 is for the relief of pain associated with sore or aching muscles of the lower back due to strain from exercise or normal household and work activities.
Product codes (comma separated list FDA assigned to the subject device)
NUH
Device Description
The Savia OTC TENS Device, Model EM-38 is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
The EM-38 is a selectable dual channel TENS device operated by 4.5 V (3xAAA-Alkaline batteries). It comes with a convenient belt that features 4 sewn-in permanent electrodes and build-in wires and a receptacle for the control unit. There are 4 selectable pre-programmed output waveforms to choose from and the intensity levels are adjustable from 0 to 152 mA. Running times can be adjusted from 22 to 31 min. Other information displayed on the LCD display are operation mode, output waveform (programs) output strength, time remaining and battery low warning. A lock function provides extra safety for the user.
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)
Testing of the Savia OTC TENS Device, Model EM-38 includes functional performance testing and electrical safety testing. The device is manufactured to comply with the following international standards:
EN 60601-1, Medical Equipment - part 1: General Requirements for Safety, 1990+A1;1993+A2;1995+A13;1996
EN 60601-1-2: 2007
EN 60601-1-4; 1996+A1;1999
EN 60601-1-6;2004
EN 60601-1-2-10:2000+A1;2001
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance. Furthermore it was demonstrated by a Usability Study that the labeling was sufficient for users to operate the device safely.
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
K 113321
510(K) SUMMARY
SEP 4 2012
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.90(e).
1.0 Submitter Information
Establishment Registration Name and Number:
SAVIA LTD. 4th Industry District, Fenghuang, Fuyong County, Baoan Shenzhen, Guangdong 518103 China Registration Number: 3007752599 .
Contact Person (US Agent/Official Correspondent) of the Applicant:
Mr. Guenter Ginsberg
(President) Media trade Corporation 11820 Red Hibiscus Drive Bonita Springs, FL 34135 Tel: 239 948-2001 Fax: 239 948-2002 e-mail: g.ginsberg@gmx.net
Device Information
| Basis: | New device | ||||
|---|---|---|---|---|---|
| 510(k) submission type: | Traditional | ||||
| Device Common Name: | Transcutaneous Electrical Nerve Stimulator | ||||
| Trade Name: | Savia OTC TENS Device | ||||
| Model: | EM-38 | ||||
| Classification Name: | TENS Device | ||||
| Review Panel: | Neurology | ||||
| Product Code: | NUH | ||||
| Regulation Class: | Class II | ||||
| Regulation Number: | 882.5890 |
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2.0 Predicate device Information
Sponsor: Well Life-Healthcare LTD. Device: OTC TENS for Back Pain Relief, Model WL-2407 510(k) No: K063660
3.0 Device Description
The Savia OTC TENS Device, Model EM-38 is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
The EM-38 is a selectable dual channel TENS device operated by 4.5 V (3xAAA-Alkaline batteries). It comes with a convenient belt that features 4 sewn-in permanent electrodes and build-in wires and a receptacle for the control unit. There are 4 selectable pre-programmed output waveforms to choose from and the intensity levels are adjustable from 0 to 152 mA. Running times can be adjusted from 22 to 31 min. Other information displayed on the LCD display are operation mode, output waveform (programs) output strength, time remaining and battery low warning. A lock function provides extra safety for the user.
4.0 Intended Use
The Savia OTC TENS Device, Model EM-38 is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
The standard format for the statement of indications and contradictions for use are provided hereafter.
5.0 Performance Summary
Testing of the Savia OTC TENS Device, Model EM-38 includes functional performance testing and electrical safety testing. The device is manufactured to comply with the following international standards:
EN 60601-1, Medical Equipment - part 1: General Requirements for Safety, 1990+A1;1993+A2;1995+A13;1996
EN 60601-1-2: 2007
EN 60601-1-4; 1996+A1;1999
EN 60601-1-6;2004
EN 60601-1-2-10:2000+A1;2001
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance. Furthermore it was demonstrated by a Usability Study that the labeling was sufficient for users to operate the device safely.
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2
Page -3-
6.0 Comparison to predicate device and conclusion
Compared with the predicate device, the Well-Life Model WL-2402, the Savia OTC TENS Device, Model EM-38, has the same intended use and similar technological characteristics. The differences between the two devices are minimal and do not present any safety and effectiveness issues. It is therefore concluded that the Savia OTC TENS Device, Model EM-38 is substantially equivalent to the predicate device.
| Question | YES | NO |
|---|---|---|
| Is the device intended for prescription use (21 CFR 801 Subpart D)?A | X | |
| Is the device intended for over-the-counter use (21 CFR 807 Subpart C)?A | X | |
| Does the device contain components derived from a tissue or other biologic source? | X | |
| Is the device provided sterile? | X | |
| Is the device intended for single use? | X | |
| Is the device a reprocessed single use device? | X | |
| If yes, does this device type require reprocessed validation data? | X | |
| Does the device contain a drug? | X | |
| Does the device contain a biologic? | X | |
| Does the device use software? | X | |
| Does the submission include clinical information? | X | |
| Is the device implanted? | X |
Design and Use of the Device
3
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 an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 4 2012
Savia Ltd. c/o Mr. Guenter Ginsberg President Media Trade Corporation 11820 Red Hibiscus Drive Bonita Springs, Florida 34135
Re: K113321
Trade/Device Name: TENS Back Pain Relief System, Model EM-38 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: August 17, 2012 Received: August 24, 2012
Dear Mr. Ginsberg:
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.
4
Page 2 - Mr. Guenter Ginsberg
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Image /page/4/Picture/7 description: The image shows a signature in black ink on a white background. The signature appears to be stylized and cursive, with looping strokes and connected letters. The overall impression is that of a quick, fluid signature, possibly representing the initials or name of an individual.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
| 510(k) Number (if known): | K113.321 |
|---|---|
| Device Name: | SAVIA OTC TENS Model EM-38 |
Indications for Use:
The intended use of the SAVIA OTC TENS unit Model EM-38 is for the relief of pain associated with sore or aching muscles of the lower back due to strain from exercise or normal household and work activities.
Over-The-Counter Use Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Zack Adan
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number
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