(58 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on TENS, infrared light, and heat, which are traditional medical device technologies.
Yes
The device is intended to temporarily promote relaxation of muscle tissue and temporarily increase local blood circulation where heat is indicated, which are therapeutic claims.
No
The intended use explicitly states the device is for "cosmetic use" and "promoting relaxation of muscle tissue" and "to temporarily increase local blood circulation where heat is indicted," which are therapeutic or cosmetic claims, not diagnostic ones. Diagnostic devices are used to identify a disease or condition.
No
The intended use and device description (even though not found, the intended use implies hardware) clearly describe a device that delivers electrical stimulation (TENS) and infrared light/heat, which are hardware-based modalities. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for stimulating the face for cosmetic purposes and using infrared light/heat for muscle relaxation and increased blood circulation. This is a direct interaction with the body for therapeutic or cosmetic effects.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples or any diagnostic purpose.
Therefore, this device falls under the category of a therapeutic or cosmetic device, not an IVD.
N/A
Intended Use / Indications for Use
TENS: ElectroPulse-Cosmetic is intended to stimulate the face. The device is indicated for cosmetic use.
Infrared Light and Heat: Emits energy in the necr-IR spectrum for temporarily promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where heat is indicted.
Product codes
NFO, ILY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
face
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)
Not Found
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pain Relief Technologies, Inc. c/o Mr. Kendall Gorham President 15048 SW Capstone Court Beaverton, OR 97007
FEB 1 5 2012
Re: K113724
Trade/Device Name: Electropulse - Cosmetic Regulation Number: 21 CFR 882.5890. Regulation Name: Transcutaneous electrical nerve stimulator for pain relief. Regulatory Class: II Product Codes: NFO, ILY Dated: December 15, 2011 Received: December 19, 2011
Dear Mr. Gorham:
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
1
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,
Keria Alexander
Malvina B. Eydelman, M.D.
Image /page/1/Picture/6 description: The image contains a handwritten word, "for", in cursive script. The letter 'f' has a large, sweeping loop extending both above and below the baseline, while the 'o' is a simple, rounded shape connected to the 'f'. The 'r' is a small, curved stroke that finishes with a slight upward flick.
Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
k 113724 510(k) Number:
Device Name: ElectroPulse -- Cosmetic
Indications For Use:
TENS: ElectroPulse-Cosmetic is intended to stimulate the face. The device is indicated for cosmetic use.
Infrared Light and Heat: Emits energy in the necr-IR spectrum for temporarily promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where heat is indicted.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) (Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K113724
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