To be used for temporary relief of pain associated with sore and aching muscles in the back due to strain from exercise or normal household and work activities and relief of pain of the upper and lower back associated with arthritis.

Device Description

The second-generation WiTouch Pro (a.k.a. WiTouch/Neubac) device is a battery powered transcutaneous electrical nerve stimulator (TENS) device for relieving back pain. The device is comprised of a TENS generator with integral electrodes, two replaceable "AAA" size batteries, replaceable electroconductive hydrogel pads (Gel Pads), a Mobile App to control the TENS device via Bluetooth® connection, which installs to Apple® iOS® 9.0 or higher or Android® 4.4 or higher smartphone platforms. Additionally, the TENS intensity may be increased or decreased using onboard mechanical buttons on the TENS unit enclosure. The TENS device offers an optional handheld wireless remote control via Radio Frequency (RF) connection which is sold separate and comes with one replaceable CR2032 Lithium-ion coin battery.

The device accessories are the replaceable Gel Pads, the Mobile App, and the optional wireless handheld remote control. The Gel Pads serve to gently adhere the TENS unit to a user's skin on the lower back, and serves to dissipate electrical stimulation across the surface area of the electrode. The Gel Pads are intended for single person use with the number of uses dependent upon skin type, oils, and pH levels.

The TENS unit adheres to the user's lower back across the spine in the area where pain is perceived. Once placed, a user can choose from four 30-minute preprogrammed stimulation output modes, and the level of intensity that is most comfortable. The preprogrammed modes are identified as WiTouch Pro Exclusive, High Frequency, Low Frequency, and High-Low Combo.

Accessories:

Pairs of replaceable hydrogel pads (Gel Pads) ●
Mobile Medical Application control using a smartphone via Bluetooth® ● connection (Apple® iOS® or Android® platforms)
Handheld wireless Remote Control.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the WiTouch Pro, WiTouch, Neubac device:

It's important to note that the provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. For such devices, acceptance criteria and studies typically focus on electrical safety, electromagnetic compatibility, biocompatibility, and functional performance, rather than clinical efficacy studies in the same way an AI-powered diagnostic device would require.

The document does not describe an AI/ML-powered device. It's a TENS device, and the "study" mentioned is conformity to recognized standards and non-clinical performance testing against a predicate device. Therefore, many of the requested categories for AI/ML device studies (like sample sizes for test sets, ground truth establishment, MRMC studies, standalone performance, and training set details) are not applicable here.

Acceptance Criteria and Device Performance (Not Applicable for AI/ML performance, but for device characteristics and safety standards)

Acceptance Criteria Category (General Device Safety/Performance)	Reported Device Performance
Electrical Output Parameters	- Number of Output Preprogrammed Modes: 4 (4 - TENS) - Number of Output Channels: 1 - Regulated Current or Regulated Voltage?: Voltage - Waveform: Asymmetrical biphasic (0 net DC charge) - Amplitude: 0 – 80mA (Measured @ 500 ohm load) - Pulse Width: 120 - 250μs (Preprogrammed) - Pulse Rate: 2 - 120 Hz
Safety Features	- Low battery indicator: Yes - Automatic Shut Off?: Yes - User Override Control?: Yes (Off button immediately stops treatment)
Physical and Operational Characteristics	- Power Source(s): (2) "AAA" Alkaline Batteries (TENS Unit), (1) "CR 2032" Lithium-ion coin battery (Remote Control) - Software/Firmware/Microprocessor Control?: Yes - Indicator Display: On/Off Status (Yes), Low Battery (Yes), Voltage/Current Level (No) - Timer Range: Nonadjustable (30 minutes) - Weight: 4.8 oz. w/ batteries included - Dimensions: 7.5 (w) x 3.5 (h) x 0.7 in (d)
Compliance with Recognized Standards	• FDA Recognition Number 13-79: IEC 62304 Edition 1.1 2015-06 • FDA Recognition Number 19-4: ANSI/AAMI ES60601-1:2005 Ed. 3 + C1:2009 + A1:2012 • FDA Recognition Number 19-16/19-7: ANSI/AAMI HA60601-1-11:2015/2011 • FDA Recognition 19-8. IEC 60601-1-2:2014 Ed. 4 • FDA Recognition Number 19-14: IEC 60601-1-11 Edition 2.0 2015-01 • FDA Recognition Number 17-11: IEC 60601-2-10 Edition 2.0 2012-06 • FDA Recognition Number 5-40: ISO 14971 Second edition 2007-03-01

Detailed Analysis for AI-Specific Questions (Not Applicable as per the document):

Given that this is a 510(k) for a TENS device and not an AI/ML-powered device, the following points are largely not applicable based on the provided text. The "study" here refers to non-clinical testing and conformity to engineering and safety standards, demonstrating substantial equivalence to a predicate device.

Sample size used for the test set and the data provenance:
- Not Applicable. The document describes non-clinical testing for substantial equivalence to a predicate TENS device, not a diagnostic AI test. No "test set" in the context of an AI algorithm's performance is mentioned. The device's performance characteristics (e.g., amplitude, pulse width, pulse rate) are tested against engineering specifications and compared to the predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not an AI diagnostic device requiring expert-established ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No ground truth adjudication process for AI performance is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is a direct-to-patient TENS unit, not an AI assistance tool for human readers/clinicians, so no MRMC study or AI assistance effect size is relevant or described.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The device is a standalone TENS unit, but not a standalone AI algorithm. Its performance is evaluated through non-clinical metrics (e.g., electrical output, adherence to safety standards).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For this TENS device, "ground truth" would relate to its physical and electrical properties meeting specifications and safety standards, rather than a clinical diagnostic truth. The "truth" is whether it functions as designed and is safe.
The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not Applicable. No training set or ground truth establishment for AI is mentioned.

Summary of the Device Evaluation per the Document:

The evaluation for the WiTouch Pro, WiTouch, Neubac device focused on demonstrating substantial equivalence to its predicate device (the first-generation WiTouch Pro K120398). This was achieved through:

Non-Clinical Testing: Verification, validation, and performance data of the second-generation device.
Conformity with Recognized Standards: Various IEC and ANSI/AAMI standards related to electrical safety, medical device software, and biocompatibility (though biocompatibility testing itself is not detailed, it's typically covered by standards compliance).
Comparison of Characteristics: A detailed table comparing the subject device's features (e.g., indications for use, power source, output parameters, safety features) to those of the predicate device. The document explicitly states, "The differences between the predicate device and the subject device do not raise new questions about safety or effectiveness."

The document concludes that "Clinical testing was not required to support substantial equivalence for the second-generation WiTouch Pro TENS device" because the intended use is well-established, and hardware/software verification demonstrates comparable performance to the predicate.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, featuring three human profiles in a row.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 22, 2017

Hollywog LLC Michael Treas Chief Compliance Officer 2830 Amnicola Highway Chattanooga, Tennessee 37406

Re: K171599

Trade/Device Name: WiTouch Pro, WiTouch, Neubac Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NYN Dated: August 22, 2017 Received: August 23, 2017

Dear Michael Treas:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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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 Industry and Consumer Education (DICE) 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. 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 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 Industry and Consumer Education (DICE) 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,

William J. Heetderks -S 2017.09.22 11:06:27 -04'00'

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

510(k) Number (if known) K171599

Device Name WiTouch Pro, WiTouch, Neubac

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) Summary

5.1

510(k) NUMBER:	K171599
510(k) SUBMITTER:	Hollywog, LLC2830 Amnicola HighwayChattanooga, TN 37406
ESTABLISHMENT REGISTRATION:	3008585473
CONTACT:	Michael W TreasChief Compliance Officer,Regulatory Affairs and Quality Assurance
TELEPHONE:	(423) 305-7778
DATE PREPARED:	July 20, 2017
PROPRIETARY NAMES:	WiTouch Pro / WiTouch / Neubac
PANEL:	Neurology
REGULATION NUMBER:	CFR Title 21, 882.5890
CLASSIFICATION:	Class II
PRODUCT CODES:	NUH, NYN
COMMON NAME:	Transcutaneous electrical nerve stimulator for painrelief
CLASSIFICATION NAME:	Stimulator, Nerve, Transcutaneous, Over-The-Counter.Stimulator, Electrical, Transcutaneous, ForArthritis
PREDICATE DEVICE:	WiTouch Pro K120398

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5.2 Device Description

Accessories:

Pairs of replaceable hydrogel pads (Gel Pads) ●
Mobile Medical Application control using a smartphone via Bluetooth® ● connection (Apple® iOS® or Android® platforms)
Handheld wireless Remote Control.

5.3 Intended Use

The intended use is to provide approximately thirty minutes of analgesic electrical stimulus to reduce the perception of pain by electrically stimulating peripheral nerves across healthy intact skin of the lower back.

5.4 Indications for Use

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5.5 Non-Clinical Testing

The verification, validation, performance, and human factors data presented in this 510(k) submission demonstrate the second-generation WiTouch Pro TENS device is substantially equivalent to the predicate device.

5.6 Predicate Device

The predicate device is the first-generation WiTouch Pro TENS device which cleared to market in 510(k) K120398. The predicate device is substantially equivalent to the subject device identified in this 510(k) Summary which is the second-generation WiTouch Pro device. The differences between the predicate device and the subject device do not raise new questions about safety or effectiveness. The subject device is as safe and effective as the predicate device. The following table is a characteristics comparison between the subject device and the predicate device.

5.6.1 Characteristics

Characteristic	Subject Device – K# TBDHollywog, LLCWiTouch®Pro/WiTouch®/Neubac®Models	Predicate Device - 510(k)K120398Hollywog, LLCWiTouch® ProModel 11.1500
Indications for Use	To be used for temporary reliefof pain associated with sore andaching muscles in the back dueto strain from exercise ornormal household and workactivities and relief of pain ofthe upper and lower backassociated with arthritis.	The WiTouch® ProTranscutaneous ElectricalNerve Stimulator Device isused for the symptomatic reliefand management of chronicintractable back pain and reliefof pain of the upper and lowerback associated with arthritis.It is also used for adjunctivetreatment for post-surgical andpost-trauma acute back pain.
Product Code	NUH, NYN(OTC Use)	GZJ, NYN(Prescription Use)
Anatomical Location	Upper and lower back	Upper and lower back
Power Source(s)	TENS Unit(2) "AAA" Alkaline BatteriesRemote Control(1) "CR 2032" Lithium-ioncoin battery	TENS Unit(2) "AAA" Alkaline BatteriesRemote Control(1) "CR 2032" Lithium-ioncoin battery
Low battery indicator	Yes	Yes
Average DC currentthrough electrodes when thedevice is on but no pulsesare being applied (µA)	0	0

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Number of OutputPreprogrammed Modes	44 - TENS	11 - TENS
Number of Output Channels	1	1
Regulated Current or RegulatedVoltage?	Voltage	Voltage
Waveform	Asymmetrical biphasic(0 net DC charge)	Asymmetrical biphasic(0 net DC charge)
Amplitude	0 – 80mA(Measured @ 500 ohm load)	0 – 80mA(Measured @ 500 ohm load)
Pulse Width	120 - 250μs(Preprogrammed)	120 - 240μs(Preprogrammed)
Pulse Rate	2 - 120 Hz	5 - 120 Hz
Software/Firmware/Microprocessor Control?	Yes	Yes
Automatic Overload Trip?	No	No
Automatic No-Load Trip?	No	No
Automatic Shut Off?	Yes	Yes
User Override Control?	YesOff button immediately stopstreatment	YesOff button immediately stopstreatment
Indicator Display	On/Off Status? YesLow Battery? YesVoltage/Current Level? No	On/Off Status? YesLow Battery? YesVoltage/Current Level? No
Timer Range	Nonadjustable30 minutes	Nonadjustable30 minutes 42 seconds
Compliance with 21 CFR 898	N/A, device does not containelectrode lead wires or patientcables.	N/A, device does not containelectrode lead wires orpatient cables.
Weight (lbs., oz.)	4.8 oz.w/ batteries included	4.8 oz.w/ batteries included
Dimensions (in.)[W x H x D]	7.5 (w) x 3.5 (h) x 0.7 in (d)	7.5 (w) x 3.5 (h) x 0.7 in (d)

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Voluntary Standards
• FDA RecognitionNumber 13-79: IEC62304 Edition 1.12015-06• FDA RecognitionNumber 19-4:ANSI/AAMI ES60601-1:2005 Ed. 3 + C1:2009+ A1:2012• FDA RecognitionNumber 19-16/19-7:ANSI/AAMIHA60601-1-11:2015/2011• FDA Recognition 19-8.IEC 60601-1-2:2014Ed. 4• FDA RecognitionNumber 19-14: IEC60601-1-11 Edition 2.02015-01• FDA RecognitionNumber 17-11: IEC60601-2-10 Edition 2.02012-06• FDA RecognitionNumber 5-40: ISO 14971Second edition 2007-03-01	• AAMI ANSI ES60601-1:2005/(R)2012 AndA1:2012• IEC 60601-1-2 Edition2014-02• IEC 60601-1-11 Edition1.0 2010-04• IEC 60601-2-10 Edition1.0 2012-06• AAMI/ANSI/ISO10993-5:2009• AAMI/ANSI/ISO 10993-10:2010

Voluntary Standards

• FDA RecognitionNumber 13-79: IEC62304 Edition 1.12015-06• FDA RecognitionNumber 19-4:ANSI/AAMI ES60601-1:2005 Ed. 3 + C1:2009+ A1:2012• FDA RecognitionNumber 19-16/19-7:ANSI/AAMIHA60601-1-11:2015/2011• FDA Recognition 19-8.IEC 60601-1-2:2014Ed. 4• FDA RecognitionNumber 19-14: IEC60601-1-11 Edition 2.02015-01• FDA RecognitionNumber 17-11: IEC60601-2-10 Edition 2.02012-06• FDA RecognitionNumber 5-40: ISO 14971Second edition 2007-03-01

• AAMI ANSI ES60601-1:2005/(R)2012 AndA1:2012• IEC 60601-1-2 Edition2014-02• IEC 60601-1-11 Edition1.0 2010-04• IEC 60601-2-10 Edition1.0 2012-06• AAMI/ANSI/ISO10993-5:2009• AAMI/ANSI/ISO 10993-10:2010

5.7 Conclusion

The basis for substantial equivalence for the referenced predicate device and for the second-generation WiTouch Pro TENS device is non-clinical data and conformity with recognized standards.

Clinical testing was not required to support substantial equivalence for the secondgeneration WiTouch Pro TENS device. This is due to the intended use is well established and understood, and the hardware and software verification and validation demonstrate that the second-generation WiTouch Pro TENS device performs comparably to the predicate device that is marketed for the same intended use.

Based on the performance testing and the similarities of the indications for use and the technological characteristics, it can be concluded that the second-generation WiTouch Pro TENS device is as safe and effective as, and substantially equivalent to, the predicate device.

Regulation Number and Section

§ 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).