(206 days)
The wwMed "" Model 401 is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of muscles.
This device can be described as a Class II Low Level Light treatment process employing the application of energy, which penetrates the skin surface to the underlying tissues, and triggers normal cellular functions that lead to a surgery-free, drug-free, and low cost benefit to the patient, the practitioner and the health care system. This device uses proprietary techniques and computational processes.
The provided text is a 510(k) summary for the wwMed Model 401 device, which is an infrared lamp for topical heating. It does not contain information about acceptance criteria, a study proving the device meets those criteria, or specific performance metrics.
The document mainly focuses on:
- Indications for Use: Temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting muscle relaxation through topical heating.
- Device Description: A Class II low-level light treatment process using infrared energy.
- Substantial Equivalence: To the Palomar Wong Tuy Corporation device (K024179).
- Regulatory Information: Classification, product code, and general controls.
Therefore, I cannot provide a detailed response to your request, as the necessary information (acceptance criteria, study details, sample sizes, ground truth methods, expert qualifications, adjudication, MRMC study, standalone performance) is not present in the provided text.
The text does mention:
- "A factory calibration test is conducted to verify the device is accurate and calibrated (and can maintain A factory canoration tost is ochadevewwMed "" Model 401 has benefited from design, development, testing and production procedures that conform to Quality Systems." - This refers to internal quality control, not a clinical study to establish performance against acceptance criteria.
- "This device is safe and effective for the application for which it is intended and has been tested to 1 ms ac vice is sare and efficacy." - This is a general statement of conclusion, not details of a study.
Without a clinical or performance study report, it's impossible to answer your specific questions.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.