(190 days)
Not Found
No
The device description and performance studies do not mention any AI or ML components. The device uses a simple, non-programmable micro-current waveform.
Yes
The device is used for "temporary relief of pain associated with sore and aching muscles and joints," which indicates a therapeutic purpose.
No
The device is described as providing "temporary relief of pain associated with sore and aching muscles and joints." This indicates a therapeutic or symptomatic relief function, not a diagnostic one. There is no mention of the device identifying diseases, conditions, or their causes.
No
The device description explicitly states it consists of a "small battery operated enclosure with an LCD screen and user buttons" and transmits a waveform through a cable and electrodes, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, 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.
- Device Description: The description clearly states that the device transmits a micro-current waveform to the affected body part through skin surface electrodes for pain relief. It does not involve testing samples taken from the body.
- Intended Use: The intended use is for temporary relief of pain associated with sore and aching muscles and joints. This is a therapeutic application, not a diagnostic one.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Temporary relief of pain associated with sore and aching muscles and joints due to strain from exercise or normal household and work activities.
Product codes
NUH
Device Description
PAT is an OTC medical device. This device is used for temporary relief of pain of sore and aching muscles and joints, due to strain from exercise or normal household and work activities. The device consists of a small battery operated enclosure with an LCD screen and user buttons to control the device. A monophasic micro-current waveform is transmitted to the affected body part through a cable connected via snaps to skin surface electrodes. There are 8 non-programmable modes representing 8 different body areas to treat.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
muscles and joints
Indicated Patient Age Range
Adult
Intended User / Care Setting
Clinics, hospital and home environment
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)
The conclusions drawn from the nonclinical tests described above demonstrate that the device is as safe and effective as the predicate device. The waveform used in both devices is similar with a square waveform with a 50% duty cycle as discovered with oscilloscope readings. The indications for use are very similar, both devices met the same test standards, and both use very low frequency pulses.
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).
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February 27, 2019
Marchan Medical, LLC Mark Chandler Managing Partner 165 S Ashe St. Southern Pines, North Carolina 28387
Re: K182267
Trade/Device Name: PAT (Pain Alleviation Technologies) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: January 18, 2019 Received: January 28, 2019
Dear Mark Chandler:
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 Actinclude 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Scott -S
Sincerely,
Pamela D. Digitally
D. Scott
Digitally signed by Pamela D. Scott -S Date: 2019.02.27 21:10:33 -05'00'
for 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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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K182267
Device Name PAT
Indications for Use (Describe)
Temporary relief of pain associated with sore and aching muscles and joints due to strain from exercise or normal household and work activities.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(K) Summary
PAT is an OTC medical device. This device is used for temporary relief of pain of sore and aching muscles and joints, due to strain from exercise or normal household and work activities. The device consists of a small battery operated enclosure with an LCD screen and user buttons to control the device. A monophasic micro-current waveform is transmitted to the affected body part through a cable connected via snaps to skin surface electrodes. There are 8 non-programmable modes representing 8 different body areas to treat.
| Sponsor: | Marchan Medical, LLC
165 S Ashe St
Southern Pines, NC 28387 |
|----------------------------------------------|-------------------------------------------------------------------|
| Contact Person: | Mark Chandler, MD |
| Phone: | 910-783-5285 |
| Email: | Markmd@marchanmedical.com |
| Date of Original Submission: August 15, 2018 | |
| Proprietary Name: | PAT |
| Common Name: | Transcutaneous electrical nerve stimulator (TENS) |
| Classification Name: | Stimulator, nerve, Transcutaneous, Over-the-Counter |
| Regulation Number: | 21 CFR 882.5890 |
| Regulatory Class: | II |
| Product Code: | NUH |
| Classification Panel: | Neurology |
| Predicate Device: | Painmaster MCT Patch (K130114) |
Indications for Use:
Temporary relief of pain associated with sore and aching muscles and joints due to strain from exercise or normal household and work activities.
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Basic Unit Characteristics
PAT uses Painmaster MCT Patch as the predicate device.
| Parameter | Painmaster MCT Patch
Predicate Device
(K130114) | PAT
Proposed Device
(K182267) |
|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Newmark, Inc. | Shenzhen Bless Electronic
Technology Co., Ltd. |
| Specifications Developer | | Marchan Medical, LLC |
| Product Code | NUH | NUH |
| Environment of use | Clinics, hospital and home
environment | Clinics, hospital and home
environment |
| Indications for Use | Temporary relief of pain
associated with sore and
aching muscles in the
upper and lower
extremities due to strain
from exercise or normal
household and work
activities. | Temporary relief of pain
associated with sore and
aching muscles and
joints due to strain from
exercise or normal
household and work
activities. |
| Patient Population | Adult | Adult |
| Operation Mode | Waveform: monophasic
square wave with 50%
duty cycle.
Amplitude: 42 μA
Frequency: 0.5 Hz | Waveform: monophasic
square wave. with 50%
duty cycle.
Amplitude:40 μA
Frequency: 3 Hz |
| Power Source | Primary battery only.
One time use. | Primary battery only.
3 replaceable AAA
batteries, not
rechargeable. |
| Operational Indicator | Yes, LED light | Yes, LCD screen |
| Time Range | Not adjustable, up to
300 hours | 40-55 minutes depending
on area treated |
| Housing Materials and
Construction | Plastic (ABS) enclosure | Plastic (ABS) enclosure |
| Body contact material | Electrode, CE certified | Electrode, FDA cleared |
| Maximum Average Current | 42 μΑ | 40 μΑ |
| OTC Use | Yes | Yes |
| Dimensions (in.)
W x H x D | 1.6 x 0.3 x 1 | 6 x 2.75 x 1 |
| Weight | 0.03 lb. | 0.25 lb. |
| Operating Temperature and
Humidity | 10-45°C, 20%-90% | 10-45°C, 20%-90% |
| Method of Line Current
Isolation | N/A | N/A |
| Patient Leakage Current | Type BF | Type BF |
| Normal Condition | 0 | 0 |
| Single Fault Condition | 50 μΑ | 50 μΑ |
| Average DC current through
electrodes when device is on
but no pulses being applied | N/A (Pulse is always
applied when on) | 0 |
| Number of Output Modes | 1 | 1 (8 different timings
based on body part being
treated but only one
preset waveform) |
| Number of Output Channels | 1 | 1 |
| Regulated Current of Voltage | Regulated Current | Regulated Current |
| Software/Firmware/
Microprocessor Control? | Yes | Yes |
| Automatic Overload Trip | Yes | Yes |
| Automatic No-Load Trip | Yes | Yes |
| Automatic Shut-Off | Yes | Yes |
| Indicator
Display | On/Off Status? Yes
Low Battery? No
Voltage/Current Level No | Yes |
| Compliance with Voluntary
Standards? | EN 60601-1
HA60601-1-11
IEC 60601-1-2
IEC 60601-2-10 | AAMI ES 60601-1
IEC 60601-1-2
IEC 60601-2-10 |
| Compliance with 21 CFR 898 | N/A | N/A |
| Electrode cable | 4 Inch snap | 40 inch double snap,
3.5mm |
| Parameter | Predicate Device | Proposed Device |
| Product Name | Painmaster MCT Patch | PAT |
| 510(K) number | K130114 | K182267 |
| Number of output modes | 1 | 1 (8 different timings based
on body part being treated but
only one preset waveform ) |
| Number of output channels | 1 | 1 |
| Waveform | Square monophasic,
50% duty cycle | Square monophasic,
50% duty cycle |
| Maximum output
Voltage (max) 500 Ω
2K Ω 10K Ω | 500 Ω : 22mV
2K Ω: 84mV
10K Ω: 370mV | 500 Ω :20.8 mV
2K Ω: 82.0 mV
10K Ω: 416 mV |
| Maximum output
Current (max) 500 Ω
2K Ω 10K Ω | 500 Ω : 42 μA
2K Ω: 42 μA
10K Ω: 37 μA | 500 Ω : 41.6 μA
2K Ω: 41.0 μA
10K Ω: 41.6 μA |
| Max. Phase charge @500 Ω
(Phase charge=pulse duration X
current amplitude) | 44 microcoulombs | 6.9 microcoulombs |
| Max. Average Current @500Ω | 42 μA | 41.6 μA |
| Max. Current density @500 Ω) | 0.002 mA/ cm² | 0.0016 mA/cm²
(using included 5X5cm electrodes) |
| Maximum Power Density (500 Ω) | 0.00005mW/cm² | 0.000035 mW / cm²
(using included 5X5cm electrodes) |
| Frequency (Hz) | 0.5Hz | 3 Hz |
| Pulse Duration | 1.0 sec | 0.166 sec |
| Burst Mode | N/A | N/A |
| Timer range (min) | 0-300 hours, depending on
battery life | 40-55 min selectable by
MODE. |
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Output Specifications
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The conclusions drawn from the nonclinical tests described above demonstrate that the device is as safe and effective as the predicate device. The waveform used in both devices is similar with a square waveform with a 50% duty cycle as discovered with oscilloscope readings. The indications for use are very similar, both devices met the same test standards, and both use very low frequency pulses.