(141 days)
Not Found
No
The device description focuses on basic electrical stimulation and a simple microprocessor with manual controls, with no mention of adaptive algorithms, learning, or data processing beyond basic signal generation.
Yes.
The device's intended use is to provide temporary relief of pain associated with sore and aching muscles, and for symptomatic relief and management of chronic, intractable pain and pain associated with arthritis, which are all therapeutic purposes.
No
The device description and intended use clearly state that it is for pain relief and management (therapeutic), not for diagnosis. It stimulates nerves rather than gathering information to identify a condition.
No
The device description explicitly details hardware components including a microprocessor, plastic case, buttons, coin cell power source, and electrodes.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Pain-Aid is a transcutaneous electrical nerve stimulator (TENS). It applies electrical impulses to the skin to relieve pain. It does not analyze any biological samples from the body.
- Intended Use: The intended use is for the temporary relief and management of pain, applied externally to the body.
The description clearly indicates that the device works by applying electrical stimulation to the body's surface, not by analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, and upper and lower extremities due to strain from exercise or normal household and work activities.
To be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
Product codes
NUH, NYN
Device Description
The Pain-Aid is a transcutaneous electrical nerve stimulator for relief of muscular pain and sold without prescription. Key to its use are specially shaped electrodes that allow an untrained person to properly place them on the body.
The device consists of a microprocessor and associated components powered by a coin cell and housed in a small plastic case.
The controls for the device consist of three buttons: A power button which turns the device on and off, an intensity increase button, and an intensity decrease button. This simple user interface is further augmented by distinctive shapes to allow the user to identify the controls even if they cannot see the device.
Contact to the body is made through self-adhesive electrodes. Electrical connection from the device to the electrode is made directly through snaps on the device and the electrode; no leadwires are used. The electrodes are designed with both conductive surfaces combined into a single. These electrodes are manufactured in various shapes to facilitate proper placement on the body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower back, and upper and lower extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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
MAR - 1 2012
510 k): K113032
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
- Submitters Information:
Thu-Ha Duncan PDI Works, LLC 2150 South Lee Highway Cleveland, TN 37311 423-303-9981 PDIWorks@gmail.com Prepared June 1, 2011
- Device Identification:
Classification Name: Transcutaneous Nerve Stimulator. Trade/Proprietary Name: Pain-Aid Classification: Class II (21 CFR 882.5890) Product Code: NUH, NYN
- Identification of Predicate Devices:
The PDI Works Pain-Aid is of comparable type and substantially equivalent to the following predicate devices:
Endurance Therapeutics Therapeutic Massage Companion, K060846 Empi Select, K061650
- Device Description:
The Pain-Aid is a transcutaneous electrical nerve stimulator for relief of muscular pain and sold without prescription. Key to its use are specially shaped electrodes that allow an untrained person to properly place them on the body.
The device consists of a microprocessor and associated components powered by a coin cell and housed in a small plastic case.
The controls for the device consist of three buttons: A power button which turns the device on and off, an intensity increase button, and an intensity decrease button. This simple user interface is further augmented by distinctive shapes to allow the user to identify the controls even if they cannot see the device.
Contact to the body is made through self-adhesive electrodes. Electrical connection from the device to the electrode is made directly through snaps on the device and the electrode; no leadwires are used. The electrodes are designed with both conductive surfaces combined into a single .
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These electrodes are manufactured in various shapes to facilitate proper placement on the body.
5. Intended Use:
To be used for temporary relief of pain associated with sore and aching muscles in the upper and To be used for temporary relever extremities due to strain from exercise or normal household and work activities. It is also intended to relieve chronic pain and pain due to arthritis.
6. Technological Characteristics
devices:
| | Pain-Aid | Therapeutic Massage
Companion | Empi Select |
|--------------------------------|-----------------------------------------------|-----------------------------------------------|---------------------------------------------------------------|
| Intended Use | Muscular Pain Relief | Muscular Pain Relief | Muscular Pain Relief,
Chronic and Arthritis
Pain Relief |
| Output Waveform | Asymmetrical
Biphasic | Asymmetrical
Biphasic | Asymmetrical
Biphasic |
| Technology / Control
System | Microprocessor
Control,
Battery Powered | Microprocessor
Control,
Battery Powered | Microprocessor
Control,
Battery Powered |
| Patient Connection | Self-adhesive
Electrodes | Self-adhesive
Electrodes | Self-adhesive.
Electrodes |
| Safety | Limited Power,
Simple User Interface | Limited Power | Prescription Device |
Comparison of actual output under various loads and operating parameters shows no significant difference in the Pain-Aid and the predicate devices.
7. Conclusions:
The PDI Works Pain-Aid has the same intended use and similar technological characteristics as the The I Dr Works I am 71d his also cansement (K060846) and Empi Select (K061650). cleared devices finclapedia massage Companies (six ) (six minor differences do not impact the safety or effectiveness of the device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 1 2012
PDI Works, LLC c/o Ms. Thu-Ha Duncan President 2150 South Lee Highway Cleveland, TN 37311
Re: K113037
Trade/Device Name: Pain-Aid Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Codes: NUH, NYN Dated: February 7, 2012 Received: February 14, 2012
Dear Ms. Duncan:
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
3
Page 2 -- Ms. Thu-Ha Duncan
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kusia Alexander
Image /page/3/Picture/7 description: The image shows the handwritten word "for" in cursive script. The letter "f" has a large, looping descender that extends below the baseline, and the "o" and "r" are connected in a fluid, continuous stroke. The writing appears to be done with a pen or marker, and the ink is dark against a white background. The overall impression is one of casual, flowing handwriting.
Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K113037 510(k) Number (if known):
Device Name:
Pain-Aid
Indications for Use:
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, and upper and lower extremities due to strain from exercise or normal household and work activities.
To be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number k 113037
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