(118 days)
The intended use of the NM-7000 is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for;
- Temporary relief of minor muscle and joint pain, and stiffness -
- The temporary relief of minor joint pain associated with arthritis -
- The temporary increase in local circulation where applied -
- Relaxation of muscles -
The NM-7000 Personal Heating Therapeutic Device is an electric multifunctional physical energy device. Its use is to provide muscle relaxing therapy to patients via a thermal function and massage. It includes ceramics which emit far infrared radiation and is for temporary easing of muscle pains, joint aches, and stiffening.
This device is made up of the main mat, auxiliary mat, frame, 5ball, 9ball external light projector, Leg holding heater as well as a regulator that can regulate and control the function of the device. Inside the main mat, 7 internal heating roller type ceramics, which can massage from the cervical vertebra to the lumbar, have been installed. A motor that can operate the heating ceramics top down, the main pcb, and a temperature sensor that can control the temperature are attached to the internal heating ceramics.
When massaging the cervical vertebra to lumbar, place the upper body over the main mat, and place the leg on the auxiliary mat which has the heating function. Also, when massaging the leg, it can be used the other way. The internal light projector moves and massages the area where the muscle has cramped and is aching and at the same time, provides thermotherapy that can relax the muscle.
The 5ball or 9ball Tourmanium projector was designed in a way it can manually provide thermotherapy and stimulation for the aching area and can easily be selected according to the aching area.
The leg holding heater can additionally provide thermotherapy for the knee or calf and was designed in a way it can be attached and fixed after wrapping the frame with a integrated Velcro band.
The main mat and auxiliary mat are both separate module types and are installed above the frame. They should be connected with the Velcro of each mat area, attached, and fixed.
The connection cable that can link the main mat with the auxiliary mat provides power for the heater from the main mat to the auxiliary mat.
The electronic components of each module such as the traction motor are loaded above the lower plywood of each module.
This document is a 510(k) summary for the NUGA MEDICAL Co., Ltd. NM-7000 Personal Heating Therapeutic Device. The document focuses on establishing substantial equivalence to a predicate device (MIGUN MEDICAL INSTRUMENT Co., Ltd. HY-7000) rather than providing detailed acceptance criteria and study results for de novo approval.
Therefore, many of the requested sections regarding acceptance criteria and detailed study information for device performance (especially those related to AI or clinical effectiveness studies) are not applicable or not available in this type of submission.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
The submission explicitly states: "Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-2-38 was performed, and EMC testing conducted in accordance with standard EN/IEC 60601-1-2(2001). was Temperature testing was conducted. All test results were satisfactory."
However, specific numerical acceptance criteria (e.g., maximum temperature deviation, specific EMC limits) and the detailed numerical results for each test are not provided in this 510(k) summary. The summary only gives a conclusive statement that "All test results were satisfactory."
Acceptance Criteria (General): Conformity to EN/IEC 60601-1 (general medical electrical equipment safety), EN/IEC 60601-2-38 (particular requirements for electric beds), and EN/IEC 60601-1-2 (EMC). Temperature testing also performed.
Reported Device Performance: "All test results were satisfactory."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided in the 510(k) summary. The testing mentioned (electrical, mechanical, environmental, EMC, temperature) refers to engineering and bench testing, not clinical studies with human subjects or a "test set" in the context of AI/diagnostic device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this device is a physical therapeutic device, not an AI or diagnostic device that requires expert-established ground truth for performance evaluation in the context of the 510(k) summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is 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:
This information is not applicable. This device is a standalone physical therapeutic device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. There is no algorithm in the sense of AI or diagnostic interpretation being evaluated. The device's function is mechanical and thermal, primarily for massage and heat therapy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not applicable. The "ground truth" for this device's regulatory review is its conformity to safety and performance standards (IEC/EN 60601 series) and its substantial equivalence to a predicate device for its stated indications for use (muscle relaxation, temporary pain relief, increased local circulation).
8. The sample size for the training set:
This information is not applicable. There is no "training set" in the context of AI or machine learning for this device.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as above.
§ 890.5880 Multi-function physical therapy table.
(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).