(175 days)
Models: uLumb-9530A、uLumb-9531A、uLumb-9532A、uLumb-9533A、LQ-9525B:
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities.
Notel : The electrode on the stimulator is used in the waist.
Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg,
Heating: To be used for temporary relief of minor aches and pains.
Models: uNeck-9512A, uNeck-9517B, uNeck-9517B, uNeck-9519A, uNeck-9521A, uNeck-9529A, LO-9535 A: Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.
The Electronic Stimulator is a portable and battery-powered TENS device with multiple models, offering both electrical pulse stimulation and heating function in one device.
The device consists of a controller that has built-in metal electrodes and accessories of a remote control, an adapter, and/or a pair of gel electrodes, an external connection coupling. The external connection coupling is used to connect the gel electrodes to the device. All models are powered by internal rechargeable battery and charged by the adapter. And all accessories, including the remote control, adapter, gel electrodes, external connection coupling can only be changed or replaced by a qualified person.
The functions of the device are controlled by the device controller and the remote control, where the remote control establishes a connection with the device controller through wireless signals. The device has five stimulation modes and one heating mode, through the metal electrodes to provide users with waist or nape stimulation and heat generation to warm and comfortable waist or nape muscles. And the heating function is controlled by a heat/temperature key and can only be run on metal electrodes, it is cannot be operated alone. The heating temperature does not exceed 43 degrees Celsius at the same time. In addition, the device is also equipped with a pair of gel electrodes, which can be used to stimulate different parts of the body (shoulder, waist, back, back of neck (nape), arm, and leg).
The device has 13 models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A, the 13 models differ in appearance, size, battery capacity, number of keys on the stimulator, the specification of electrodes equipped, and some output parameters, the details can refer to the "Model list form" of the Device Description file in this application.
This submission is for an Electronic Stimulator with multiple models, intended for temporary relief of pain associated with sore and aching muscles and temporary relief of minor aches and pains through electrical stimulation and heating.
The acceptance criteria and device performance are described below based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/ML device but rather a Transcutaneous Electrical Nerve Stimulator (TENS), the "acceptance criteria" are compliance with established safety and performance standards for similar devices. The "reported device performance" refers to the successful completion or compliance with these standards and tests. No specific accuracy or diagnostic performance metrics typically associated with AI/ML devices are present.
| Acceptance Criteria (Standards & Tests Met) | Reported Device Performance |
|---|---|
| Biocompatibility Safety: | The materials of the patient-directly contacting components of the Electronic Stimulator were evaluated and passed biocompatibility testing. This included: |
| * ISO 10993-5 Biological Evaluation of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity | * Passed ISO 10993-5 (In Vitro Cytotoxicity) |
| * ISO 10993-10 Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization | * Passed ISO 10993-10 (Irritation and Skin Sensitization) |
| EMC and Electrical Safety: | Electrical safety and Eye safety testing was performed to and passed the following standards: |
| * IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance –Collateral standard: electromagnetic compatibility | * Passed IEC 60601-1-2 (EMC) |
| * IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance | * Passed IEC 60601-1 (General Safety and Essential Performance) |
| * IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment | * Passed IEC 60601-1-11 (Home Healthcare Environment Safety) |
| * IEC 60601-2-10 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators | * Passed IEC 60601-2-10 (Nerve and Muscle Stimulators Specific Requirements) |
| Software Verification and Validation: | Software documentation consistent with a moderate level of concern was submitted. System validation testing demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. |
| Other Performance Verification: | |
| * Electrodes performance test to verify current dispersion and shelf-life according to FDA Guidance -Shelf Life of Medical Device and ASTM F1980-07 Standard. | * Electrodes performance test was conducted to verify current dispersion and shelf-life, and it passed. |
| * Waveform and output test according to FDA Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning. | * Waveform and output test was conducted to verify output specifications, and it passed. The maximum output voltage, current, pulse duration, and frequency are within acceptable ranges for TENS devices, and the net charge per pulse is 0µC, achieved through a balanced waveform. Maximum temperature setting is 43°C, which is within the acceptable range for heating functions in similar devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical trials or AI/ML model evaluation with patient data. Instead, performance data is based on non-clinical testing of the device itself against established safety and performance standards. Therefore, information about sample size for a test set, data provenance (country of origin, retrospective/prospective), number of experts, or adjudication methods is not applicable in the context of this 510(k) summary for a TENS device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as this is a traditional medical device submission based on non-clinical engineering and safety performance, not an AI/ML device relying on expert-annotated ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as above.
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, and no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-based algorithm; it is a physical electrostimulation device with heating functions.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For this traditional medical device, "ground truth" refers to compliance with recognized consensus standards and predetermined engineering specifications for safety and effectiveness. This is demonstrated through objective physical and electrical testing, biocompatibility assessment, and software verification, rather than clinical outcomes or expert consensus on diagnostic images.
8. The Sample Size for the Training Set
Not applicable. This device does not employ machine learning or an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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).