(113 days)
Not Found
No
The document describes a standard TENS device with preprogrammed modes and a mobile app for control. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
Explanation: The device is a transcutaneous electrical nerve stimulator (TENS) intended for "temporary relief of pain associated with sore and aching muscles" and "relief of pain of the upper and lower back associated with arthritis," which are therapeutic claims.
No
The device is a Transcutaneous Electrical Nerve Stimulator (TENS) intended for the relief of pain, not for diagnosing conditions.
No
The device description clearly states it is a battery-powered transcutaneous electrical nerve stimulator (TENS) device, which is a hardware component. While it includes a mobile app for control, the core medical function is performed by the physical TENS unit.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The WiTouch Pro is a Transcutaneous Electrical Nerve Stimulator (TENS) device. It applies electrical stimulation to the skin to relieve pain. It does not analyze any biological samples.
- Intended Use: The intended use is for the temporary relief of pain associated with sore and aching muscles and arthritis in the back. This is a therapeutic use, not a diagnostic one.
The description clearly indicates that the device is a TENS unit for pain relief, which falls under the category of physical medicine devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NUH, NYN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper and lower back
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)
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.
Clinical testing was not required to support substantial equivalence for the second-generation 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.
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.
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/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
1
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
2
Indications for Use
510(k) Number (if known) K171599
Device Name WiTouch Pro, WiTouch, Neubac
Indications for Use (Describe)
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.
| 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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3
5. 510(k) Summary
5.1
| 510(k) NUMBER: | K171599 |
|---|---|
| 510(k) SUBMITTER: | Hollywog, LLC |
| 2830 Amnicola Highway | |
| Chattanooga, TN 37406 | |
| ESTABLISHMENT REGISTRATION: | 3008585473 |
| CONTACT: | Michael W Treas |
| Chief 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 pain |
| relief | |
| CLASSIFICATION NAME: | Stimulator, Nerve, Transcutaneous, Over-The- |
| Counter. | |
| Stimulator, Electrical, Transcutaneous, For | |
| Arthritis | |
| PREDICATE DEVICE: | WiTouch Pro K120398 |
4
5.2 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.
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
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.
5
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# TBD
Hollywog, LLC
WiTouch®
Pro/WiTouch®/Neubac®
Models | Predicate Device - 510(k)
K120398
Hollywog, LLC
WiTouch® Pro
Model 11.1500 |
|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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. | The WiTouch® Pro
Transcutaneous Electrical
Nerve Stimulator Device is
used for the symptomatic relief
and management of chronic
intractable back pain and relief
of pain of the upper and lower
back associated with arthritis.
It is also used for adjunctive
treatment for post-surgical and
post-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 Batteries
Remote Control
(1) "CR 2032" Lithium-ion
coin battery | TENS Unit
(2) "AAA" Alkaline Batteries
Remote Control
(1) "CR 2032" Lithium-ion
coin battery |
| Low battery indicator | Yes | Yes |
| Average DC current
through electrodes when the
device is on but no pulses
are being applied (µA) | 0 | 0 |
6
| Number of Output
Preprogrammed Modes | 4
4 - TENS | 1
1 - TENS |
|-----------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Number of Output Channels | 1 | 1 |
| Regulated Current or Regulated
Voltage? | 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? | Yes
Off button immediately stops
treatment | Yes
Off button immediately stops
treatment |
| Indicator Display | On/Off Status? Yes
Low Battery? Yes
Voltage/Current Level? No | On/Off Status? Yes
Low Battery? Yes
Voltage/Current Level? No |
| Timer Range | Nonadjustable
30 minutes | Nonadjustable
30 minutes 42 seconds |
| Compliance with 21 CFR 898 | N/A, device does not contain
electrode lead wires or patient
cables. | N/A, device does not contain
electrode lead wires or
patient 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) |
7
| Voluntary 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 | • AAMI ANSI ES60601-
1:2005/(R)2012 And
A1:2012
• IEC 60601-1-2 Edition
2014-02
• IEC 60601-1-11 Edition
1.0 2010-04
• IEC 60601-2-10 Edition
1.0 2012-06
• AAMI/ANSI/ISO
10993-5:2009
• 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.