(338 days)
The WS-501 Heat Lamp may be used for the 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, and the relaxation of muscles. In addition, the WS-501 Heat Lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The WS-501 Heat Lamp is used to provide topical heating to the body. The WS-501 Heat Lamp is specially engineered using a rare earth ceramic plate. Emission spectrum ranges from 0.5 to 13,500 microns. The emission heating plate life ranges from 5,000 to 10,000 hours of usage. 110 volt power, 20 watts with hi and low switch. Hand held model also features a table top stand. Warm up time before use is 3 to 5 min.
This document does not contain information related to specific acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert qualifications, or adjudication methods for the WS-501 Heat Lamp.
The provided text is a 510(k) summary for the WS-501 Heat Lamp, which explicitly states:
- (b)(1)(2)(3) Substantial equivalence is not based on an assessment of performance data. (Page 6c)
This indicates that the device's pre-market notification was based on demonstrating substantial equivalence to existing predicate devices (WS Portable Infrared Heat Lamp, CAI Industries, 510k # K-954577; TDP CQ-27 Heat Lamp, Lhasa Medical, Inc, 510k #: K-003538; Firard II TDP Lamp, Helio Medical Supplies, 510k #: K-960036), rather than through a study evaluating specific performance criteria against predefined acceptance thresholds. The equivalence is based on similar design, indications for use, technological characteristics (heating plate method, power, output), function, and operation.
Therefore, I cannot populate the requested tables or answer the specific questions about acceptance criteria, performance data, or study methodologies.
§ 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.