(51 days)
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
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 provided text describes the JKH Stimulator Plus, a Transcutaneous Electrical Nerve Stimulation (TENS) unit, Powered Muscle Stimulation (PMS) unit, and heating device. The document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial.
Therefore, the requested information elements such as sample sizes for test/training sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone performance studies are not available in this document. The document primarily relies on engineering and performance comparisons to a predicate device and compliance with voluntary standards.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical format of a clinical study or performance goal. Instead, it presents a comparison table between the subject device (JKH Stimulator Plus, K191151) and its predicate device (JKH Stimulator Plus, K182203), highlighting technical specifications. The "acceptance criteria" here are implicitly that the subject device's technical specifications are substantially equivalent to the predicate device and fall within safe and effective ranges for TENS/PMS devices.
| Parameter | Subject Device (K191151) Performance (Models: PL-029K5BL, PL-029K15, PL-029T) | Predicate Device (K182203) Performance (Models: PL-029K12, PL-029K13) |
|---|---|---|
| Intended Use | Over-The-Counter & Prescription (TENS, PMS, Heating) | Over-The-Counter & Prescription (TENS, PMS, Heating) |
| Power Source(s) | Rechargeable or non-rechargeable battery | Rechargeable or non-rechargeable battery |
| Average DC current (no pulses) | 0 | 0 |
| Number of Output Modes | PL-029K5BL: 6-8, PL-029K15: 1-4, PL-029T: 8 | PL-029K12: 8, PL-029K13: 8 |
| Number of Outputs | 1-2 | 1 |
| Regulated Current or 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 |
| Indicator Display: Low Battery? | Yes | Yes |
| Indicator Display: 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 |
| Max output voltage (500Ω) | PL-029K5BL: 65, PL-029K15: 36, PL-029T: 46 | PL-029K12: 57.6, PL-029K13: 46.0 |
| Max output voltage (2KΩ) | PL-029K5BL: 132, PL-029K15: 72, PL-029T: 92 | PL-029K12: 96.0, PL-029K13: 90.4 |
| Max output voltage (10KΩ) | PL-029K5BL: 180, PL-029K15: 125, PL-029T: 136 | PL-029K12: 134, PL-029K13: 124 |
| Max output current (500Ω) | PL-029K5BL: 130, PL-029K15: 72, PL-029T: 92 | PL-029K12: 115.2, PL-029K13: 92.0 |
| Max output current (2KΩ) | PL-029K5BL: 66, PL-029K15: 36, PL-029T: 47 | PL-029K12: 48.0, PL-029K13: 45.2 |
| Max output current (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: 50~500, PL-029K15: 100, PL-029T: 104 | PL-029K12: 100, PL-029K13: 92 |
| Pulse period (mSec) | PL-029K5BL: 2 | PL-029K12: 6.4 |
| Frequency (Hz) | PL-029K5BL: 1 | PL-029K12: 1.2 |
| 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 | N/A (Subject device does not specify burst mode parameters) | N/A (Predicate device does not specify burst mode parameters) |
| ON time (sec) | Not explicitly stated as a range for the subject device | 3.4~20 |
| OFF time (sec) | Not explicitly stated as a range for the subject device | 1~2.5 |
General Acceptance Criteria (Implicitly Met by Substantial Equivalence and Standards Compliance):
- Safety: Demonstrated by compliance with voluntary standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5, ISO 10993-10) and the lack of new safety issues compared to the predicate device.
- Effectiveness: Demonstrated by substantial equivalence to a legally marketed predicate device for the stated indications for use (pain relief, muscle performance, blood circulation, temporary relaxation of muscle spasm, prevention of disuse atrophy, muscle re-education, range of motion, prevention of post-surgical venous thrombosis). The document highlights that the output parameters are "therapeutically effective with either device."
- Performance: Technical specifications (voltage, current, pulse width, frequency, etc.) are within ranges considered appropriate for TENS/PMS devices and comparable to the predicate.
- Biocompatibility: Electrodes and materials are compliant with ISO 10993 standards.
- Software Validation: Software verification was carried out according to FDA guidance.
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is a 510(k) submission based on substantial equivalence. No clinical test set data from actual patients is presented as part of the evidence. The "tests" mentioned are non-clinical engineering and standard compliance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No ground truth for clinical performance was established in this context. The evaluation is based on engineering specifications and comparison to a predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI-assisted device, nor is it a diagnostic device where MRMC studies are typically performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For this submission, the "ground truth" for proving safety and effectiveness is tied to compliance with recognized standards and the demonstration of substantial equivalence to a predicate device that has already been cleared.
8. The sample size for the training set:
- Not Applicable. No training set data for an AI/algorithm is mentioned.
9. How the ground truth for the training set was established:
- Not Applicable. No training set data for an AI/algorithm is mentioned.
§ 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).