(190 days)
Not Found
No
The summary describes a standard TENS device and does not mention any AI or ML components or capabilities.
Yes
The device is used for symptomatic relief, management of pain, and adjunctive treatment for acute back pain, which are therapeutic applications.
No
Explanation: The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) used for symptomatic relief and management of pain. It stimulates peripheral nerves to reduce pain perception. It does not perform any diagnosis or identify diseases or conditions.
No
The device description explicitly states it consists of a battery-powered current generator with integral electrodes and replaceable hydrogel pads, indicating it is a hardware device that delivers electrical stimulation.
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The WiTouch™ Pro is a Transcutaneous Electrical Nerve Stimulator (TENS). It works by applying electrical stimulation to the skin to relieve pain. It does not analyze any biological samples from the patient.
- Intended Use: The intended use clearly states it's for pain relief and management, not for diagnosing or monitoring a condition based on biological samples.
Therefore, based on the provided information, the WiTouch™ Pro is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
The intended use is to provide analgesic electrical stimulus to reduce the perception of back pain by electrically stimulating peripheral nerves across the skin (transcutaneously).
Product codes (comma separated list FDA assigned to the subject device)
GZJ, NYN
Device Description
The WiTouch™ Pro medical device is a Transcutaneous Electrical Nerve Stimulator (TENS) used to reduce the perception of pain by electrically stimulating peripheral nerves across the skin (transcutaneously). The design consists of a battery powered current generator with integral electrodes and replaceable electrical dispersive hydrogel pads (gel-pads). One side of the adhesive gel-pad adhere to the integral electrode, and the other side adhere the device to the healthy intact skin of the patient's back to provide a transcutaneous analgesic electrical stimulus to the painful area.
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
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): 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
510(k) Summary per 21 CFR 807.92
510(k) # K120398
Page 1 of 4
AUG 1 6 2012
Hollywog, LLC 510(k) SUBMITTER: 2830 Amnicola Highway Chattanooga, TN 37406
ESTABLISHMENT REGISTRATION: 3008585473
Michael W. Treas. CONTACT: Chief Compliance Officer
DATE PREPARED: August 15, 2012
PROPRIETARY NAME: WiTouch™ Pro
PANEL: Neurology
REGULATION NUMBER: CFR Title 21, 882.5890
CLASSIFICATION: Class II
PRODUCT CODES: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief); NYN (Stimulator, Electrical, Transcutaneous, For Arthritis)
- COMMON NAME: Transcutaneous electrical nerve stimulator for pain relief.
Description:
The WiTouch™ Pro medical device is a Transcutaneous Electrical Nerve Stimulator (TENS) used to reduce the perception of pain by electrically stimulating peripheral nerves across the skin (transcutaneously). The design consists of a battery powered current generator with integral electrodes and replaceable electrical dispersive hydrogel pads (gel-pads). One side of the adhesive gel-pad adhere to the integral electrode, and the other side adhere the device to the healthy intact skin of the patient's back to provide a transcutaneous analgesic electrical stimulus to the painful area.
Indications for Use:
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.
Intended Use:
The intended use is to provide analgesic electrical stimulus to reduce the perception of back pain by electrically stimulating peripheral nerves across the skin (transcutaneously).
1
510(k) Summary per 21 CFR 807.92
510(k) # K120398
Page 2 of 4
Accessories:
The device utilizes hydrogel pads) for achieving the indications for use and intended use. The composition of the gel-pads is common materials found in the electrode industry. The uniqueness of the gel-pads is in the shape. The maximum average power density of the electrodes with the gel-pads applied is less than 0.25 watts per square centimeter of electrode conductive surface area to reduce the risk of thermal burns which is consistent with the referenced predicate devices.
| 510(k) # | Predicate Proprietary
Trade Name | Predicate Regulation, Classification, and Product Code(s) | |
|-------------------------------------------------------------------------------------------------------------------|-------------------------------------|-----------------------------------------------------------|------------------------------------|
| K061650 | Empi SELECT® | CFR Title 21, Sec. 882.5890, Class II, GZJ, NYN | |
| K061516 | Staodyn® Max Preset TENS | CFR Title 21, Sec. 882.5890, Class II, GZJ, NYN | |
| 510(k) Number | K120398 | K061650 | K061516 |
| Device Name and Model | WiTouch™ Pro | Empi® Select | Staodyn®
Max preset TENS |
| Manufacturer | Hollywog | EMPI | Compex Technologies |
| TENS Device Power Source (DC battery) | Battery 1.5VDC
(2-Alkaline AAA) | Battery 1.5VDC
(3-Alkaline AAA) | Battery 1.5VDC
(3-Alkaline AAA) |
| Number of Output Modes | 4 | 4 | 4 |
| Number of Output Channels: Synchronous or Asynchronous? | 1 Channel Asynchronous | 2 Channels Asynchronous | 2 Channels Synchronous |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes |
| Automatic Shut Off? | Yes | Yes | Yes |
| User Override Control? | Yes | Yes | Yes |
| Indicator On/Off Status? | Yes | Yes | Yes |
| Display: Low Battery? | Yes | Yes | No |
| Voltage/Current Level? | No | No | No |
| Timer Range (minutes) | 30 | 1 to 30 | 1 to 30 |
| Weight (lbs., oz.) | 4.8 oz.
w/ batteries included | 4.9 oz.
w/ batteries included | 5.15 oz.
w/ batteries included |
| Dimensions (in.) [W x H x D] | 7.5"(W) x 3.5(H)" x
0.7"(D) | 2.38"(W) x 1.38"(H) x
4.31"(D) | 2.5"(W) x 5.25"(H) x
1.0"(D) |
| Housing Material and Construction | Silicone & ABS | Plastic | Plastic |
| Waveform (e.g., pulsed monophasic, biphasic) | Pulsed biphasic | Pulsed biphasic | Pulsed biphasic |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | Square | Square | Square |
| For multiphasic waveforms only: Symmetrical phases? | No | No | Yes |
| Step-1 and Step-3
Phase Duration (include units), (state range, if applicable), (both phases, if asymmetrical) | 120μs | 0 to 400μs at 50% peak amplitude | 0 to 300μs |
| Step-2
Phase Duration (include units), (state range, if applicable), (both phases, if asymmetrical) | 480μs | 0 to 400μs at 50% peak amplitude | 0 to 300μs |
| Maximum Current Density, (mA/cm², r.m.s.) | 0.12mA@500 Ω |