(211 days)
Not Found
No
The document describes a TENS/PMS device with manual controls and optional wireless control via a remote or Bluetooth app. There is no mention of AI or ML capabilities in the intended use, device description, or performance studies. The software verification is mentioned as being carried out according to FDA guidance for software in medical devices, which does not inherently imply AI/ML.
Yes
The device is intended for the symptomatic relief and management of chronic pain, post-surgical and post-trauma acute pain, pain associated with arthritis, and relief of muscle spasm, among other therapeutic uses.
No
The indicated uses and device description clearly state that this device is used for therapeutic purposes (pain relief, muscle stimulation, increasing local blood flow, warming), not for diagnosing medical conditions.
No
The device description explicitly states it delivers electric pulses through electrodes and includes physical buttons for operation, indicating it is a hardware device with integrated software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device delivers electric pulses and heat to the user's body through electrodes. It is used for pain relief, muscle stimulation, and increasing blood circulation. These are all external applications to the body, not tests performed on samples taken from the body.
- Intended Use: The intended uses listed are related to pain management, muscle performance, and blood circulation, all of which are achieved through external stimulation and heating. There is no mention of analyzing biological samples.
Therefore, this device falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Over-The-Counter Use:
TENS (Modes 1, 2, 4, 5, 6, 8):
PL-029K12 and PL-029K13 are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
PL-029K12 and PL-029K13 are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The device of PL-029K12 may be used during sleep. The device of PL-029K12 is labeled for use only with its own compatible electrodes.
PMS (also called EMS, Modes 1, 3, 7):
PL-029K12 and PL-029K13 are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
PL-029K12 and PL-029K13 are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating: The device of PL-029K13 is intended for temporary relief of minor aches and pains.
Prescription Use:
PL-029K12 and PL-029K13 are intended for the following use:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
- Temporary relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion
- Increase of local blood flow in the treatment area
- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX, NYN, IRT, GZJ, GZI, IPF
Device Description
The subject device delivers electric pulses generated to the user's body areas such as the back and foot through the electrodes. The devices include operating of ON/OFF button, intensity increase button, intensity decrease button, and could be attached to electrodes. The device has multiple program modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). In addition, the device may also provide heat/temperature. While used in the heating mode, the device is coupled with electronically controlled electrodes to provide automatic thermal heat to the skin with the maximum temperature of 43 degrees C for temporary relief of minor aches and pains.
The device could be easily operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, providing heat/temperature and displaying/burning calories if needed. The optional wireless control via a remote or Bluetooth APP could provide a secondary operation way to the user, who could be able to wirelessly realize the functions mentioned above.
The electrodes cleared include the electrode patches/pads and electrode garments, which could be packaged together with the 510(k)-cleared devices or packaged separately as the replacement electrodes for 510(k)-cleared devices. The exact percentage of ingredients used in the electrode patch/pad may be withheld as the trade secret.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, waist, back, arm, leg, abdomen, buttocks, calf muscles, lower extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use and Prescription 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)
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:
- (a) IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance".
- (b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
- (c) IEC 60601-2-10 "Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators".
- (d) ISO 10993-5 "Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity".
- (e) ISO 10993-10 "Biological evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization".
In addition to the compliance of voluntary standards, the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
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.
K162517, K031017, K140333, K153704
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized depiction of an eagle. The FDA acronym and the full name of the agency are written in blue.
June 21, 2021
JKH USA, LLC Bill Quanqin Dai Manager 1142 S. Diamond Bar Blvd, #861 Diamond Bar, California 91765
Re: K182203
Trade/Device Name: JKH Stimulator Plus Regulation Number: 21 CFR 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, NYN, IRT, GZJ, GZI, IPF
Dear Bill Quanqin Dai:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 14, 2019. Specifically, FDA is updating this SE Letter as an administrative correction. FDA has added a new product code, GZI, to better categorize your device technology to be consistent with your 510(k) Summary.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Amber Ballard, OHT5: Office of Neurological and Physical Medicine Devices, by email (Amber.Ballard(@)fda.hhs.gov) or phone (240-402-9983).
Sincerely,
Vivek J. Pinto -S
Vivek Pinto, PhD Division Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
March 14, 2019
JKH USA. LLC Bill Quanqin Dai Manager 1142 S. Diamond Bar Blvd. #861 Diamond Bar, California 91765
Re: K182203
Trade/Device Name: JKH Stimulator Plus Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, NYN, IRT, GZJ, IPF Dated: October 22, 2018 Received: January 2, 2019
Dear Bill Quanqin Dai:
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 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
2
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 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 mediation-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).
Sincerely.
Vivek J. Pinto -S
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
3
Indications for Use
510(k) Number (if known) K182203
Device Name JKH Stimulator Plus
Indications for Use (Describe) Over-The-Counter Use:
TENS (Modes 1, 2, 4, 5, 6, 8):
PL-029K12 and PL-029K13 are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
PL-029K12 and PL-029K13 are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The device of PL-029K12 may be used during sleep. The device of PL-029K12 is labeled for use only with its own compatible electrodes.
PMS (also called EMS, Modes 1, 3, 7):
PL-029K12 and PL-029K13 are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
PL-029K12 and PL-029K13 are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating: The device of PL-029K13 is intended for temporary relief of minor aches and pains.
Prescription Use:
PL-029K12 and PL-029K13 are intended for the following use:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
- Temporary relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion
- Increase of local blood flow in the treatment area
- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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5
510(k) Summary
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter's Information
Submitter: JKH USA, LLC Mailing Address: 1142 S. Diamond Bar Blvd, #861, Diamond Bar, CA 91765 Contact Person: Dr. Bill Quanqin Dai Tel: 909-929-9896 Email: Bill(@jkhUSA.com Date of Preparation: 06/29/2018
2. Subject Device
Trade/Device Name: JKH Stimulator Plus Common Name: Transcutaneous Electrical Nerve Stimulation (TENS) unit. Powered Muscle Stimulation (PMS) unit, and heating for pain relief, blood circulation, and muscle performance Regulation Medical Specialtv: Neurology Review Panel: Neurology Product Code: NUH, NGX, NYN, GZJ, GZI, IPF, IRT Regulation Number: 21 CFR 882.5890 Device Class: II Use: Over-The-Counter (OTC) and Prescription
3. Predicate device
Predicate Device: Electronic Pulse Stimulator 510(k) Number: K162517 Clearance Date: April 14, 2017 Submitter: JKH Health Co., Ltd.
Predicate Device: Sys*Stim ME 208 510(k) Number: K031017 Clearance Date: May 30, 2003 Submitter: Mettler Electronics Corp.
Predicate Device: ASCEND 510(k) Number: K140333 Clearance Date: July 3, 2014 Submitter: NeuroMetrix, Inc.
Predicate Device: Strive 510(k) Number: K153704 Clearance Date: June 3, 2016 Submitter: DJO, LLC
4. Description of Subject Device
The subject device delivers electric pulses generated to the user's body areas such as the back and foot through the electrodes. The devices include operating of ON/OFF button, intensity increase button, intensity decrease button, and could be attached to electrodes. The device
6
has multiple program modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). In addition, the device may also provide heat/temperature. While used in the heating mode, the device is coupled with electronically controlled electrodes to provide automatic thermal heat to the skin with the maximum temperature of 43 ℃ for temporary relief of minor aches and pains.
The device could be easily operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, providing heat/temperature and displaying/burning calories if needed. The optional wireless control via a remote or Bluetooth APP could provide a secondary operation way to the user, who could be able to wirelessly realize the functions mentioned above.
The electrodes cleared include the electrode patches/pads and electrode garments, which could be packaged together with the 510(k)-cleared devices or packaged separately as the replacement electrodes for 510(k)-cleared devices. The exact percentage of ingredients used in the electrode patch/pad may be withheld as the trade secret.
5. Indications for Use
Over-The-Counter Use:
TENS (Modes 1, 2, 4, 5, 6, 8):
PL-029K12 and PL-029K13 are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
PL-029K12 and PL-029K13 are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The device of PL-029K12 may be used during sleep. The device of PL-029K12 is labeled for use only with its own compatible electrodes.
PMS (also called EMS, Modes 1, 3, 7):
PL-029K12 and PL-029K13 are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
PL-029K12 and PL-029K13 are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating:
The device of PL-029K13 is intended for temporary relief of minor aches and pains.
Prescription Use:
PL-029K12 and PL-029K13 are intended for the following use:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
7
- Relief of pain associated with arthritis
- Temporary relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion
- Increase of local blood flow in the treatment area
- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles
6. Summary of Substantial Equivalence
The following comparison Table 1 summarizes the comparison between the subject device and the predicate device, indicating the intended use and technical characteristics of the subject device are substantially equivalent to those of the predicate device.
| Subject Device | Predicate Device | Predicate Device | Predicate Device | Predicate Device | |
|---|---|---|---|---|---|
| 510(k) Number | K182203 | K162517 | K031017 | K140333 | K153704 |
| Submitter/ | |||||
| Manufacturer | JKH USA, LLC | JKH Health Co., Ltd. | Mettler Electronics | ||
| Corp. | NeuroMetrix, Inc. | DJO, LLC | |||
| Device Name/Model | PL-029K12 and | ||||
| PL-029K13 | PL-029K12 and | ||||
| PL-029K13 | Sys*Stim ME 208 | ASCEND | Strive | ||
| Intended Use | Over-The-Counter Use: |
TENS (Modes 1, 2, 4, 5, 6,
8):
PL-029K12 and PL-
029K13 are used for
temporary relief of pain
associated with sore and
aching muscles in the
shoulder, waist, back, arm,
and leg, due to strain from
exercise or normal
household and work
activities.
PL-029K12 and PL-
029K13 are also intended
for symptomatic relief and
management of chronic,
intractable pain and relief
of pain associated with
arthritis.
The device of PL-029K12
may be used during sleep.
The device of PL-029K12
is labeled for use only with
its own compatible
electrodes.
PMS (also called EMS,
Modes 1, 3, 7):
PL-029K12 and PL-
029K13 are used to
stimulate healthy muscles
in order to improve and
facilitate muscle
performance. To be used
for the improvement of | TENS:
To be used for
temporary relief of
pain associated with
sore and aching
muscles in the
shoulder, waist, back,
arm, and leg, due to
strain from exercise or
normal household and
work activities.
It is also intended for
symptomatic relief and
management of
chronic, intractable
pain and relief of pain
associated with
arthritis.
PMS:
To stimulate healthy
muscles in order to
improve and facilitate
muscle performance.
To be used for the
improvement of
muscle tone and
firmness, and for
strengthening muscles
in the arms, abdomen,
legs, and buttocks. Not
intended for use in any
therapy or for the
treatment of any
medical conditions or
diseases.
It is also intended to | 1. Symptomatic relief
of chronic intractable
pain, acute post
traumatic pain or
acute post-surgical
pain
2. Temporary relation
of muscle spasm
3. Prevention of
postsurgical phlebo-
thrombosis through
immediate
stimulation of calf
muscles
4. Increasing local
blood circulation
5. Prevention or
retardation of disuse
atrophy
6. Muscle re-
education
7. Maintaining or
increasing range of
motion | ASCEND is intended
for use as a
transcutaneous
electrical nerve
stimulation device for
temporary relief of
pain associated with
sore and aching
muscles in the lower
extremities due to
strain from exercise
or normal household
and work activities.
ASCEND is intended
for use as a
transcutaneous
electrical nerve
stimulation device for
the symptomatic
relief and
management of
chronic intractable
pain.
The device may be
used during sleep.
The device is labeled
for use only with
compatible
NeuroMetrix
electrodes. | Prescription Use:
The StriveTM TENS
device is used for the
symptomatic relief
and management of
chronic, intractable
pain and relief of
pain associated with
arthritis. It is also
used as an adjunctive
treatment for post-
surgical and post-
trauma acute pain.
As a TENS device,
indications are for the
following conditions:
- Symptomatic relief
and management of
chronic, intractable
pain - Adjunctive
treatment for post-
surgical and post-
trauma acute pain - Relief of pain
associated with
arthritis
Over the Counter
Use:
The StriveTM TENS
device is used for:
-temporary relief of
pain associated with
sore and aching
muscles due to strain
from exercise or
normal household |
| | muscle tone and firmness,
and for strengthening
muscles in the arms,
abdomen, legs, and
buttocks. Not intended for
use in any therapy or for the
treatment of any medical
conditions or diseases.
PL-029K12 and PL-
029K13 are also intended to
temporarily increase local
blood circulation in the
healthy muscles of lower
extremities.
Heating:
The device of PL-029K13
is intended for temporary
relief of minor aches and
pains.
Prescription Use:
PL-029K12 and PL-
029K13 are intended for the
following use:
- Symptomatic relief and
management of chronic,
intractable pain - Adjunctive treatment for
post-surgical and post-
trauma acute pain - Relief of pain associated
with arthritis - Temporary relaxation of
muscle spasm - Prevention or retardation
of disuse atrophy - Muscle re-education
- Maintaining or increasing
range of motion - Increase of local blood
flow in the treatment area - Prevention of post-
surgical venous thrombosis
through immediate
stimulation of calf muscles | temporarily increase
local blood circulation
in the healthy muscles
of lower extremities.
Heating:
Temporary relief of
minor aches and pains. | | | and work activities.
-the symptomatic
relief and
management of
chronic, intractable
pain and relief of
pain associated with
arthritis. |
| Prescription or OTC | OTC and Prescription | OTC | Prescription | OTC | OTC and Prescription |
| Power Source(s) | Rechargeable or non-
rechargeable battery | Rechargeable battery | Main (line) voltage | Rechargeable battery | Rechargeable battery |
| Compliance with
Voluntary Standards? | Yes | Yes | Yes | Yes | Yes |
| Compliance with 21
CFR 898? | Yes | Yes | Yes | Yes | Yes |
| Functions and design | Electrical stimulation and
heat | Electrical stimulation
and heat | Electrical stimulation | Electrical stimulation | Electrical stimulation |
| Maximum skin
temperature | 43 °C | 43 °C | N/A | N/A | N/A |
| Maximum output
voltage (Volts +/-
20%) at 500Ω | PL-029K12: 57.6
PL-029K13: 46.0 | PL-029K12: 57.6
PL-029K13: 46.0 | 92 | 50 | 30 |
| Maximum output
voltage (Volts +/- | PL-029K12: 96.0
PL-029K13: 90.4 | PL-029K12: 96.0
PL-029K13: 90.4 | 144 | 100 | 110 |
| 20%) at 2KΩ | | | | | |
| Maximum output voltage (Volts +/- 20%) at 10kΩ | PL-029K12: 134
PL-029K13: 124 | PL-029K12: 134
PL-029K13: 124 | 166 | 100 | 110 |
| Maximum output current (mA +/- 20%) at 500Ω | PL-029K12: 115.2
PL-029K13: 92.0 | PL-029K12: 115.2
PL-029K13: 92.0 | 184 | 100 | 60 |
| Maximum output current (mA +/- 20%) at 2KΩ | PL-029K12: 48.0
PL-029K13: 45.2 | PL-029K12: 48.0
PL-029K13: 45.2 | 72 | 50 | 55 |
| Maximum output current (mA +/- 20%) at 10KΩ | PL-029K12: 13.4
PL-029K13: 12.4 | PL-029K12: 13.4
PL-029K13: 12.4 | 17 | 10 | 11 |
| Pulse Width (µSec) | PL-029K12: 100
PL-029K13: 92 | PL-029K12: 100
PL-029K13: 92 | 200 | 100 | 70300 |156.2
| Frequency (Hz) | PL-029K12: 1.2
PL-029K13: 1.2178.5 | PL-029K12: 1.2156.2
PL-029K13: 1.2178.5 | 180 | 60100 | 5122 |
| Maximum Phase charge (µC) at 500Ω | PL-029K12: 23.0
PL-029K13: 16.9 | PL-029K12: 23.0
PL-029K13: 16.9 | 33.5 | 10 | 18 |
| Maximum current density (mA/cm²) at 500Ω | PL-029K12: 3.26
PL-029K13: 3.29 | PL-029K12: 3.26
PL-029K13: 3.29 | 9.12 | 0.51 | 0.33 |
| Maximum average power density (mW/cm²) at 500Ω | PL-029K12: 1.44
PL-029K13: 1.26 | PL-029K12: 1.44
PL-029K13: 1.26 | 12 | 3.6 | 5.53 |
Table 1. Comparison between the subject device and the predicate device
8
9
7. Substantial Equivalence
As shown in the above comparison Table 1, the subject device submitted is the same as the predicate device in the predicate K162517. While there are no differences between the subject device and the predicate device in K162517, the differences between the subject device and the other predicate devices in K031017, K140333, and K153704 do not raise any new issues of safety or effectiveness, as discussed below.
Both the subject device and the predicate device have the technical specifications that are within the range of other FDA cleared transcutaneous electrical nerve stimulators. For example, in the predicate K153704, the difference of maximum output voltage, maximum output current, maximum current density, and maximum average power density is 40V (110V versus 150V at 10KΩ), 40mA versus 100mA at 500Ω), 10.69 mA/cm² (0.31mA/cm² versus 0.1-11 mA/cm² at 500Ω), and 39.08 mW/cm² (4.92mW/cm² versus 44 mW/cm² at 500Ω), respectively, between the K153704-cleared device and its predicate device. In addition, the output current, phase charge, current density, and average power density are set and delivered at a one-by-one level by the user to a strong but comfortable sensation, so the output voltage, output current, phase charge, and average power density delivered are therapeutically effective with either device. Furthermore, the subject device in this submission and the predicate device in K162517 are exactly the same from the same manufacturer, and have the same maximum output voltage, maximum output current, maximum phase charge, maximum current density, and maximum average power density at 50002, 2KS2, and 10KS2. Therefore, the differences of maximum output voltage, maximum output current, maximum phase charge, maximum current density, and maximum average power density between the subject device and the predicate device does not raise new questions of safety or effectiveness.
The difference of frequencies between the subject device and the predicate device does not raise new types of safety or effectiveness questions because (i) neither device gives the user control over frequency, (ii) both devices are using standard TENS stimulation frequencies, (iii) random frequency stimulation is within the standard practice for TENS devices and is used in the predicate device, and (iv)
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the effectiveness of TENS is not dependent on the use of modulated pulse trains such as those generated by the predicate device, and can be equally achieved through the random frequency stimulation as delivered by the subject device. Similarly, the same case could be seen in the predicate K140333: The K140333-cleared device has a varying frequency between 60 and 100 Hz, while its predicate device cycles through a range of frequencies between 2 and 100 Hz. In addition, in the predicate K140333, the pulse width of the K140333-cleared device is fixed at 100 uSec while that of its predicate device is from 30-220 uSec. The same case applies to the subject device in this submission: the predicate devices are with pulse widths that range from 70-300 uSec, while the subject device has a pulse width of 100 uSec and 92 uSec for the PL-029K13, respectively. Therefore, the difference of pulse width also does not raise new issues of safety or effectiveness.
In addition, the subject device PL-029K13 itself also has a heating mode, and is comparable to the predicate device that could deliver electrical stimulation and heat separately and simultaneously in K162517. The subject device delivers heat through the substantially equivalent technology to the predicate device, and does not raise new concerns of safety or effectiveness.
As demonstrated, there are no new safety or effectiveness issues concerning the subject device, which offers substantially equivalent technical specifications. features, intended use, safety, and effectiveness to the predicate device.
8. Non-Clinical Tests Performed
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.
- (a) IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance".
- (b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
- (c) IEC 60601-2-10 "Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators".
- (d) ISO 10993-5 "Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity".
- (e) ISO 10993-10 "Biological evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization".
In addition to the compliance of voluntary standards, the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The same electrode pads and garments cleared in the predicate K162517 and other biocompatible electrodes described in this submission could apply to the subject device, such as conductive patches/pads, shoes, belts, wraps, sleeves, socks, insoles, gloves, shirts, shorts, and suits, and will not change the safety or effectiveness. Concerns of the safe and proper use of the electrodes have been fully addressed through details in the Labeling.
9. Conclusion
The tests and comparison performed demonstrate the subject device is substantially equivalent to the predicate device. Therefore, the subject device is as safe and effective as the predicate device that has been legally marketed in the United States.