(543 days)
Not Found
No
The document describes a standard TENS device and does not mention any AI or ML components or capabilities.
Yes
The device is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles and dysmenorrhea, all of which are considered therapeutic uses.
No
The "Intended Use / Indications for Use" section states that the device is "designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles" and "for temporary relief of pain associated with dysmenorrhea (menstrual cramps)". This indicates a therapeutic or pain management function, not a diagnostic one. The "Device Description" also explains how it works to block pain signals.
No
The device description explicitly states that the LIVIA is a TENS device that sends electrical pulses into the body through the skin by the use of electrodes. This indicates the presence of hardware components (the TENS unit and electrodes) that deliver the therapy, making it a hardware-based medical device, not software-only.
Based on the provided information, the Livia device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Livia is designed for symptomatic relief and management of pain, and temporary relief of pain associated with various conditions. This involves applying electrical stimulation to the body, not analyzing samples taken from the body.
- Device Description: The description identifies the Livia as a TENS device, which works through electrotherapy by sending electrical pulses through the skin. This is a physical intervention, not an in vitro diagnostic process.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
Therefore, the Livia device falls under the category of a therapeutic device (specifically, a TENS device for pain relief) rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Livia is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities. The Livia is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.
Product codes (comma separated list FDA assigned to the subject device)
NUH
Device Description
The LIVIA is a TENS device. TENS is an acronym for Transcutaneous Electrical Nerve Stimulator, and it works as a pain treatment system through electrotherapy. The unit sends light electrical pulses into the body through the skin by the use of electrodes, which are placed over peripheral nerves. The TENS unit works by sending high frequency electrical signals that are both continuous and mild to block out those pain signals that are being delivered to the brain. The Livia device was designed with specific pulse frequency and pulse length that are suitable for its intended use. When these pain signals are halted, pain isn't felt by the reactive area and the patient get relief. Low frequency bursts of mild electrotherapy also help the natural pain control response to activate, and these beta endorphins ease the pain that are being felt by the patient.
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
adult patients
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)
A clinical study was performed to assess the efficacy of the Livia device in treating dysmenorrhea. The study, entitled "A Randomized, Controlled, Multi-Center, Crossover, Prospective, Double-blind Clinical Study to Assess the Effectiveness and Safety of Livia® Transcutaneous Electrical Nerve Stimulation (TENS) in Women Suffering from Primary Dysmenorrhea," was a randomized, controlled, multi-center, crossover, doubleblind clinical study assessing the Livia® device in women suffering from primary dysmenorrhea. The study, conducted at four study sites, compared results from the Livia to a sham device. The trial evaluated the safety and efficacy of Livia vs. Sham using 65 Participants at 4 different sites.
Subjects in the study experienced a decline in pain as assessed by the Visual Analogue Scale (VAS). The use of Livia succeeded in reducing the VAS score by an average of 28.1 points. The use of the Sham device reduced the VAS score by 17.6 points. A statistically significant difference between Livia and the Sham device was observed (P
§ 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
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May 4, 2020
LifeCare Ltd. % Irving Wiesen Official Correspondent Cohen, Tauber, Spievack & Wagner 420 Lexington Avenue - Suite 2400 New York, New York 10170
Re: K183110
Trade/Device Name: Livia Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: June 11, 2019 Received: March 3, 2020
Dear Irving Wiesen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Vivek J. Pinto -S
Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K183110
Device Name Livia
Indications for Use (Describe)
The Livia is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower (extremities) leg due to strain from exercise or normal household work activities. The Livia is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication.
Type of Use (Select one or both, as applicable)
| Registration Use (Part 1 CFR 221 Subpart B) | |
|---|---|
| Service-Type Contracting (Part 1 CFR 221 Subpart C) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5: 510(K) SUMMARY
The assigned 510(K) Number: K183110
1. Submitter's Identification:
LifeCare Ltd.
Zipori St.2 1424602, Tiberias, Israel
Date Summary Prepared: May 1, 2020
Contact Person: Irving L. Wiesen, Esq. Law Offices of Irving L. Wiesen P.C. 420 Lexington Avenue - Suite 2400 New York, New York 10170 Tel 212-381-8774 Fax 646-536-3185 Email: iwiesen@wiesenlaw.com
2. Name of the Device:
Livia
3. Common Name and Classification:
Stimulator, Nerve, Transcutaneous, Over-The-Counter 21 CFR Part 882.5890 Requlation: Product Code: NUH
4. Predicate Device Information:
LIVIA K163153
5. Device Description:
The LIVIA is a TENS device. TENS is an acronym for Transcutaneous Electrical Nerve Stimulator, and it works as a pain treatment system through electrotherapy. The unit sends light electrical pulses into the body through the skin by the use of electrodes, which are placed over peripheral nerves. The TENS unit works by sending high frequency electrical signals that are both continuous and mild to block out those pain signals that are being delivered to the brain. The Livia device was designed with specific pulse frequency and pulse length that are suitable for its intended use. When these pain signals are halted, pain isn't felt by the reactive area and the patient get relief. Low frequency bursts
4
of mild electrotherapy also help the natural pain control response to activate, and these beta endorphins ease the pain that are being felt by the patient.
6. Indication For Use:
The Livia is designed for symptomatic relief and management of chronic pain. and 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. The Livia is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medications.
7. Comparison to Predicate Devices:
The Livia proposed device technological characteristics are identical to Livia K163153. The indications for use are the same except that the Indications for Use of the proposed device includes dysmenorrhea (menstrual cramps) as a kind of pain which may be treated by the device. In the User Manual of the predicate device, menstrual cramps are included as an appropriate use of the device, along with illustrations of electrode placement for such use. The purpose of the instant 510K is to include menstrual pain in the types of pain included in the Indications for Use, for the education of the consumer who may be searching for a product which is appropriate for that use, before or at the point of sale. While the predicate device already contains menstrual pain as a use of the device, LifeCare has conducted a clinical trial designed to show efficacy and safety in that indication. The report of this trial is included in this application. 020_Performance Testing-Clinical.
TABLE 1: Indication For Use Comparison Table
| Parameter | Proposed Device | Predicate Device |
|---|---|---|
| LIVIA | ||
| Indication | ||
| For Use | The Livia is designed for | |
| symptomatic relief and | ||
| management of chronic pain, | ||
| and for temporary relief of | ||
| pain associated with sore and | The Livia is designed for | |
| symptomatic relief and | ||
| management of chronic pain, | ||
| and for temporary relief of pain | ||
| associated with sore and aching |
Comparison Tables - Technological Characteristics
5
| | 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 and
for temporary relief of pain
associated with
dysmenorrhea (menstrual
cramps).
It should be applied to normal,
healthy, dry and clean skin of
adult patients, and is to be
used for stimulate healthy
muscles in order to improve
and facilitate muscle
performance. | muscles in the shoulder, waist,
back, neck, upper extremities
(arm) and lower (extremities)
leg due to strain from exercise
or normal household workIt should be applied to normal,
healthy, dry and clean skin of
adult patients, and is to be used
for stimulate healthy muscles in
order to improve and facilitate
muscle performance. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Class | II | II |
| Product
Code | NUH | NUH |
| Regulation
Number | 21 CFR 882.5890 | 21 CFR 882.5890 |
Table 2: Basic Unit Characteristics Comparison Table
| Parameter | Proposed | Predicate - | Significant |
|---|---|---|---|
| Device | Livia | Differences | |
| 510(k) Number | K163153 | N/A | |
| Device Name and Model Number | LIVIA | LIVIA | N/A |
| Manufacturer | Life Care Ltd | Life Care Ltd | N/A |
| Power Source(s) | 3.7V Lithium- | 3.7V Lithium- | ldentical |
| ion battery | ion battery | ||
| (rechargeable) | (rechargeable) | ||
| Method of Line Current Isolation | Output is | Output is | ldentical |
| electrically | electrically | ||
| disabled when | disabled when | ||
| connect to | connect to | ||
| charger, by | charger, by |
6
| | | means of
microprocessor
charging circuit | means of
microprocessor
charging circuit | | |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----------|
| Patient Leakage Current
- Normal Condition (μΑ) | | Battery
powered
(