(51 days)
Not Found
No
The document describes a TENS/PMS device with manual controls and optional wireless control via remote or Bluetooth app. There is no mention of AI or ML in the intended use, device description, or performance studies. The software verification is mentioned, but it is described in the context of standard medical device software guidance, not AI/ML specific development.
Yes
The device is described as a TENS (Transcutaneous Electrical Nerve Stimulation) and PMS (Powered Muscle Stimulator) device, indicated for both over-the-counter and prescription use to relieve pain, manage chronic conditions, stimulate muscles, and temporarily increase local blood circulation, all of which are therapeutic purposes.
No
The device is described as delivering electric pulses for symptomatic relief and management of pain (TENS) and to stimulate healthy muscles (PMS) or provide heat. These are therapeutic applications, not diagnostic ones, as there is no mention of it being used to identify or analyze medical conditions.
No
The device description explicitly states that the device delivers electric pulses and includes operating elements like buttons. It also mentions electronically controlled electrodes and the ability to provide heat. While there is mention of an optional wireless control via a remote or Bluetooth APP, the core functionality and components described are hardware-based, not solely software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
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 Function: The description clearly states that this device delivers electric pulses and potentially heat directly to the user's body through electrodes. It is used for pain relief, muscle stimulation, and increasing blood circulation.
- Intended Use: The intended uses listed are all related to applying energy to the body for therapeutic or performance enhancement purposes (TENS, PMS, Heating). None of the intended uses involve testing biological samples.
- Device Description: The description focuses on the physical components that interact with the body (electrodes, buttons, wireless control) and the types of energy delivered (electric pulses, heat). There is no mention of components for handling or analyzing biological samples.
Therefore, based on the provided information, this device falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Over-The-Counter Use:
TENS:
PL-029K.5BL, PL-029K.15, and PL-029T 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-029K.5BL, PL-029K15, and PL-029T are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The device of PL-029K5BL and PL-029K15 may be used during sleep. The device of PL-029K15 is labeled for use only with its own compatible electrodes.
PMS:
PL-029K5BL, PL-029K15, and PL-029T 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-029K5BL, PL-029K15, and PL-029T are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating:
The device of PL-029T is intended for temporary relief of minor aches and pains.
Prescription Use:
TENS:
PL-029K5BL, PL-029K15, and PL-029T 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
PMS:
PL-029K5BL, PL-029K15, and PL-029T are intended for the following use:
- 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, GZJ, IPF, IRT
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 elements, such as the ON/OFF button, intensity increase button, and 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 biocompatible electrode patch/pad is withheld as the trade secret and may be disclosed as requested.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, arm, leg, healthy muscles in the arms, abdomen, legs, and buttocks, healthy muscles of lower extremities, treatment area, calf muscles
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)
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) ANSI AAMI ES60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
- (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 electrode pads and garments cleared in the predicate K182203 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.
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/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
June 21, 2019
Jkh Usa. LLC Bill Quanqin Dai, PhD Manager 1142 S. Diamond Bar Blvd. #861 Diamond Bar, California 91765
Re: K191151
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, GZJ, IPF, IRT Dated: May 14, 2019 Received: May 23, 2019
Dear Dr. 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.
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Vivek Pinto, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191151
Device Name JKH Stimulator Plus
Indications for Use (Describe) Over-The-Counter Use:
TENS:
PL-029K.5BL, PL-029K.15, and PL-029T 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-029K.5BL, PL-029K15, and PL-029T are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The device of PL-029K5BL and PL-029K15 may be used during sleep. The device of PL-029K15 is labeled for use only with its own compatible electrodes.
PMS:
PL-029K5BL, PL-029K15, and PL-029T 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-029K5BL, PL-029K15, and PL-029T are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating:
The device of PL-029T is intended for temporary relief of minor aches and pains.
Prescription Use:
TENS:
PL-029K5BL, PL-029K15, and PL-029T 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
PMS:
PL-029K5BL, PL-029K15, and PL-029T are intended for the following use:
- 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
3
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)
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4
K191151
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: 04/26/2019
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 Specialty: Neurology Review Panel: Neurology Product Code: NUH, NGX, NYN, GZJ, IPF, IRT Regulation Number: 21 CFR 882.5890 Device Class: II Use: Over-The-Counter (OTC) and Prescription
3. Predicate device
Trade Name: JKH Stimulator Plus 510(k) Number: K182203 Clearance Date: March 14, 2019 Submitter: JKH USA, 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 elements, such as the ON/OFF button, intensity increase button, and 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 ℃ 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 biocompatible
5
electrode patch/pad is withheld as the trade secret and may be disclosed as requested.
5. Indications for Use
Over-The-Counter Use:
TENS:
PL-029K5BL, PL-029K15, and PL-029T 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-029K5BL, PL-029K15, and PL-029T are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The device of PL-029K5BL and PL-029K15 may be used during sleep. The device of PL-029K5BL and PL-029K15 is labeled for use only with its own compatible electrodes.
PMS:
PL-029K5BL, PL-029K15, and PL-029T 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-029K5BL. PL-029K15, and PL-029T are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
Heating:
The device of PL-029T is intended for temporary relief of minor aches and pains.
Prescription Use:
TENS:
PL-029K5BL, PL-029K15, and PL-029T 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
PMS:
PL-029K5BL, PL-029K15, and PL-029T are intended for the following use:
- 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
6
substantially equivalent to those of the predicate device.
| Parameter & Predicate
Device(s) | Subject Device | Predicate Device | |
---|---|---|---|
510(k) Number | K191151 | K182203 | |
Submitter/Manufacturer | JKH USA, LLC | JKH USA, LLC | |
Device Name/Model | JKH Stimulator Plus, PL-029K5BL, PL- | ||
029K15, and PL-029T | JKH Stimulator Plus, PL-029K12 and PL- | ||
029K13 | |||
Intended Use | Over-The-Counter Use: | ||
TENS: | |||
PL-029K5BL, PL-029K15, and PL-029T 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-029K5BL, PL-029K15, and PL-029T are | |||
also intended for symptomatic relief and | |||
management of chronic, intractable pain and | |||
relief of pain associated with arthritis. | |||
The device of PL-029K5BL and PL-029K15 | |||
may be used during sleep. The device of PL- | |||
029K5BL and PL-029K15 is labeled for use | |||
only with its own compatible electrodes. | |||
PMS: | |||
PL-029K5BL, PL-029K15, and PL-029T 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-029K5BL, PL-029K15, and PL-029T are | |||
also intended to temporarily increase local | |||
blood circulation in the healthy muscles of | |||
lower extremities. | |||
Heating: | |||
The device of PL-029T is intended for | |||
temporary relief of minor aches and pains. | |||
Prescription Use: | |||
TENS: | |||
PL-029K5BL, PL-029K15, and PL-029T 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
PMS:
PL-029K5BL PL-029K15 and PL-029T are | Over-The-Counter Use:
TENS:
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:
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 | |
| | | | |
| | | intended for the following use: - 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 | |
| Prescription or OTC | | OTC and Prescription | OTC and Prescription |
| Power Source(s) | | Rechargeable or non-rechargeable battery | Rechargeable or non-rechargeable battery |
| - Method of Line Current
Isolation | | Battery Supply | Battery Supply |
| - Patient Leakage Current:
Normal Condition (μΑ) | | N/A | N/A |
| - Patient Leakage Current: Single
Fault Condition (μΑ) | | N/A | N/A |
| Average DC current through
electrodes when device is on but
no pulses are being applied (mA) | | 0 | 0 |
| Number of Output Modes | | PL-029K5BL: 6-8
PL-029K15: 1-4
PL-029T: 8 | 8 |
| Number of Output | | 1-2 | 1 |
| -Synchronous/Alternating? | | N/A | N/A |
| -Method of Channel Isolation | | N/A | N/A |
| Regulated Current or Regulated
Voltage? | | Voltage | Voltage |
| Software/Firmware/
Microprocessor Control? | | Yes | Yes |
| Automatic Overload Trip? | | No | No |
| Automatic No-Load Trip? | | Yes | Yes |
| Automatic Shut Off? | | Yes | Yes |
| User Override Control? | | Yes | Yes |
| Indicator
Display: | On/Off Status? | Yes | Yes |
| | Low Battery? | Yes | Yes |
| | Voltage/
Current Level? | Yes | Yes |
| Timer Range (minutes) | | PL-029K5BL: 10-540
PL-029K15: 10-60
PL-029T: 10-60 | PL-029K12: 10-540
PL-029K13: 10-60 |
| Compliance with Voluntary
Standards? | | Yes | Yes |
| Compliance with 21 CFR 898? | | Yes | Yes |
| Weight (g) | | PL-029K5BL: 40
PL-029K15: 35
PL-029T: 70 | PL-029K12: 25
PL-029K13: 105 |
| Dimensions (mm) [L x W x D] | | PL-029K5BL: 66x56x18
PL-029K15:70x62x16
PL-029T: 95x55x15 | PL-029K12: 69.5x36.8x14
PL-029K13: 88.5x76.5x18.2 |
| Housing Materials and
Construction | | Silicone & ABS | Silicone & ABS |
| Functions and design | | Electrical stimulation and heat | Electrical stimulation and heat |
| Maximum skin temperature | | 43°C | 43°C |
| Waveform | | Biphasic | Biphasic |
| Shape | | Rectangular | Rectangular |
| | | | |
| Maximum output voltage (Volts +/- 20%) at 500Ω | PL-029K5BL: 65
PL-029K15: 36
PL-029T: 46 | PL-029K12: 57.6
PL-029K13: 46.0 | |
| Maximum output voltage (Volts +/- 20%) at 2KΩ | PL-029K5BL: 132
PL-029K15: 72
PL-029T: 92 | PL-029K12: 96.0
PL-029K13: 90.4 | |
| Maximum output voltage (Volts +/- 20%) at 10KΩ | PL-029K5BL: 180
PL-029K15: 125
PL-029T: 136 | PL-029K12: 134
PL-029K13: 124 | |
| Maximum output current (mA +/- 20%) at 500Ω | PL-029K5BL: 130
PL-029K15: 72
PL-029T: 92 | PL-029K12: 115.2
PL-029K13: 92.0 | |
| Maximum output current (mA +/- 20%) at 2KΩ | PL-029K5BL: 66
PL-029K15: 36
PL-029T: 47 | PL-029K12: 48.0
PL-029K13: 45.2 | |
| Maximum output current (mA +/- 20%) at 10KΩ | PL-029K5BL: 18
PL-029K15: 12.5
PL-029T: 13.6 | PL-029K12: 13.4
PL-029K13: 12.4 | |
| Pulse Width (µSec) | PL-029K5BL: 505001000
PL-029K15: 100
PL-029T: 104 | PL-029K12: 100
PL-029K13: 92 | |
| Pulse period (mSec) | PL-029K5BL: 2
PL-029K15: 101000833 | PL-029K12: 6.4
PL-029T: 6840806 | |
PL-029K13: 5.6
| Frequency (Hz) | PL-029K5BL: 1500100
PL-029K15: 1
PL-029T: 1.2167 | PL-029K12: 1.2156.2
PL-029K13: 1.2178.5 | |20 | 3.4
| Maximum Phase charge (µC) at 500Ω | PL-029K5BL: 78
PL-029K15: 14.5
PL-029T: 19.3 | PL-029K12: 23.0
PL-029K13: 16.9 | |
| Maximum average current density (mA/cm²) at 500Ω | PL-029K5BL: 1.86
PL-029K15: 0.35
PL-029T: 0.40 | PL-029K12: 0.21
PL-029K13: 0.34 | |
| Maximum average power density (mW/cm²) at 500Ω | PL-029K5BL: 28
PL-029K15: 1.68
PL-029T: 2.22 | PL-029K12: 1.44
PL-029K13: 1.26 | |
| Burst Mode | (a) Pulse per burst
(b) Burst per second
(c) Burst-duration (sec)
(d) Duty Cycle | N/A | N/A |
| ON time (sec) | | 120 |10 | 1~2.5 |
| OFF time (sec) | | 0
| Additional features | | N/A | N/A |
Table 1. Comparison between the subject device and the predicate device
7
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7. Substantial Equivalence
The differences between the subject device in this submission and the predicate device in K182203 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, the difference of maximum output voltage, maximum output current, maximum phase charge, maximum average current density, and maximum average power density is 7.4V (65V versus 57.6V at 500Ω), 14.8mA (130mA versus 115.2mA at 500Ω), 55μC (78μC versus 23μC at 500Ω), 1.52mA/cm² versus 0.34mA/cm² at 500Ω), and 26.56 mW/cm² (28mW/cm² versus 1.44mW/cm² at 500Ω), respectively, between the subject device and the predicate device. In addition, the output current,
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phase charge, average 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, average current density, and average power density delivered are therapeutically effective with either device. Therefore, the differences of maximum output voltage, maximum output current, maximum phase charge, maximum average 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) both devices are using standard TENS stimulation frequencies, (ii) random frequency stimulation is within the standard practice for TENS devices and is used in the predicate device, and (iii) 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 K182203: While the K182203-cleared device has a pulse width of 100 uSec, its predicate devices are with pulse widths that range from 70-300 uSec. Therefore, the difference of pulse width also does not raise new issues of safety or effectiveness.
In addition, the subject device PL-029T itself also has a heating mode, and is comparable to the predicate device PL-029K13 that could deliver electrical stimulation and heat separately and simultaneously in K182203. 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, the differences between the subject and predicate devices do not affect the intended use or alter the fundamental technology of the device. 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) ANSI AAMI ES60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
- (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 electrode pads and garments cleared in the predicate K182203 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
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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.