(278 days)
No
The description focuses on the physical components and electrical parameters of a TENS device and its conductive wrap. There is no mention of AI or ML algorithms for data processing, decision-making, or personalized therapy.
Yes
The device is described as a "Transcutaneous Electrical Nerve Stimulator (TENS) for Pain Relief," which is a type of therapeutic device used to alleviate pain symptoms.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain." This describes a therapeutic, not a diagnostic, purpose.
No
The device description explicitly details a physical component, the "Silver Wrap," which is a hardware component used to transfer energy to the patient. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Description: The EPRT Bodihealth TENS System is a Transcutaneous Electrical Nerve Stimulator. It applies electrical currents to the patient's body (transcutaneous) for pain relief.
- Intended Use: The intended use is for temporary symptomatic relief and management of pain, which is a therapeutic application, not a diagnostic one involving testing bodily samples.
The device's function and intended use clearly fall under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EPRT Bodihealth TENS System (Transcutaneous Electrical Nerve Stimulator for Pain Relief) with Silver Wrap is intended for temporary symptomatic relief and management of chractable pain and as an adjunctive treatment in the management of postsurgical and post-traumatic pain.
Product codes
GZJ
Device Description
The Bodihealth TENS system was previously described in K052836. The Silver Wrap is the component of the Bodihealth System that is used to transfer the energy from the Bodihealth device to the patient. It consists of a MediSponge foam 100 to which silver fabric is laminated, and then covered by urethane. The silver wrap is one-piece and consists of (a) a Urethane outer layer, (b) an adhesive layer, (c) a silver plated nylon conductive layer and (d) a foam layer that acts as the material that contacts the patient. The silver wrap functions as the means to conduct a maximum current of 3 milliamperes at 0.000732 Hz for 23 minutes. The electric currents produced are compatible with the natural electric currents of the human body. The BodiHealth device is used to generate pulses which may be varied in frequency and pulse duration by potentiometer type controls. The pulses are amplified and coupled to output jacks to which the wrap is attached by wires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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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).
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MAR 1 2 2014 KI31675
Section 8: Special 510(k) Summary
The following information is provided as required by 21 CFR § 807.92 for EPRT Technologies' 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
- Sponsor: EPRT Technologies 1925 Angus Avenue, Unit D Simi Valley, CA 93063 USA
- Contact: Katherine Blake President EPRT Technologies. 1925 Angus Avenue, Unit D Simi Valley, CA 93063 USA (805) 526-2184
| Date of Submission: | June 4, 2013 |
|---|---|
| Proprietary Name: | EPRT Bodihealth TENS System with Silver Wrap |
| Common Name: | Transcutaneous Electrical Nerve Stimulator for Pain Relief |
| Regulatory Class: | Class II |
| Product Codes: | GZJ |
| Regulation Number: | 21CFR 882.5890 |
| Predicate Device(s): | EPRT Bodihealth System (K052836) with Foam and |
| Rubber Wrap |
Device Description:
The Bodihealth TENS system was previously described in K052836. The Silver Wrap is the component of the Bodihealth System that is used to transfer the energy from the Bodihealth device to the patient. It consists of a MediSponge foam 100 to which silver fabric is laminated, and then covered by urethane.
1
The silver wrap is one-piece and consists of (a) a Urethane outer layer, (b) an adhesive layer, (c) a silver plated nylon conductive layer and (d) a foam layer that acts as the material that contacts the patient.
The silver wrap functions as the means to conduct a maximum current of 3 milliamperes at 0.000732 Hz for 23 minutes. The electric currents produced are compatible with the natural electric currents of the human body.
Technological Characteristics:
The BodiHealth device is used to generate pulses which may be varied in frequency and pulse duration by potentiometer type controls. The pulses are amplified and coupled to output jacks to which the wrap is attached by wires.
Intended Use:
The EPRT Bodihealth TENS System (Transcutaneous Electrical Nerve Stimulator for Pain Relief) with Silver Wrap is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
Comparison to Predicate Devices:
The EPRT Bodihealth TENS System with Silver Wrap has the same intended use and similar technological characteristics as the Bodihealth TENS System with previous with the Foam and Rubber Wrap described in K052836. Bench testing has proven the Silver Wrap to be equivalent to the Foam and Rubber Wrap previously used.
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Design Control Summary
| Design Input | Design Output | Verification/Validation |
|---|---|---|
| Obtain foam component | ||
| equivalent to that used in | ||
| predicate wrap | Medi-Sponge 100 selected as a | |
| suitable replacement | Engineering Testing meets the | |
| requirements as shown in this | ||
| section. | ||
| Simplify the device from a two- | ||
| piece system to a single-piece | ||
| wrap | Successful development of a | |
| one-piece wrap | Improved and simplified as | |
| described in User Preference | ||
| Testing shown in this section. | ||
| Reduce the resistance | ||
| encountered in the previous | ||
| rubber Strap/Conco foam. | One-piece silver wrap reduced | |
| the resistance as required in | ||
| design input | Engineering testing | |
| demonstrated that the silver | ||
| wrap has over 1/24th the | ||
| resistance as the predicate (see | ||
| User Preference Testing shown | ||
| in this section) | ||
| Improve uniform energy transfer | ||
| from the Bodihealth device to the | ||
| patient. | Silver fabric is silver plated over | |
| nylon that is then laminated to | ||
| foam with a hot melt grid | ||
| adhesive. The grid pattern allows | ||
| a conductive path from the silver | ||
| fabric through the wet foam. | See Engineering Testing meets | |
| the requirements as shown in | ||
| this section | ||
| Ensure that wave form and | ||
| energy output of the improved | ||
| device matches that of the | ||
| predicate | Equivalent to predicate | See Engineering Testing shown |
| in this section demonstrates | ||
| equivalent waveforms to the | ||
| predicate |
Conclusion:
The EPRT Bodihealth TENS System with Silver Wrap has a similar design and the same intended use as the predicate wrap used in EPRT Bodihealth System (K052836). Biocompatibility testing and the current knowledge of the material provided by scientific literature demonstrated the appropriateness of the device materials for the proposed intended use. Engineering testing confirms that there is no change in the energy delivered to the patient due to the modification of the wrap component.
The test data demonstrate that the EPRT Bodihealth TENS System with Silver Wrap is substantially equivalent to the predicate (previous) wrap used in the device and that there is no change in the safety and effectiveness due to the modification.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a bird or abstract human figure with outstretched arms. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 12, 2013
EPRT Technologies, Inc. c/o Jeff Morgan JWM Associates LLC 15-2807 Puna Parkway Pahoa, HI 96778
Re: K131675
Trade/Device Name: EPRT Bodihealth TENS System with Silver Wrap Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: February 6, 2014 Received: February 11, 2014
Dear Mr. Morgan:
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
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Page 2 - Mr. Jeff Morgan
CFR Part 807); labeling (21 CFR Part 801); medical device 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 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/Resourcesfor You/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,
Carlos L.. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K131675
Device Name
EPRT Bodihealth TENS System with Silver Wrap
Indications for Use (Describe)
The EPRT Bodihealth TENS System (Transcutaneous Electrical Nerve Stimulator for Pain Relief) with Silver Wrap is intended for temporary symptomatic relief and management of chractable pain and as an adjunctive treatment in the management of postsurgical and post-traumatic pain.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
O Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Carlos L. Pena -S
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