SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646

• K Number: K020464
• Device Name: SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646
• Manufacturer: ROLOR ELECTRONICS CORP.
• Date Cleared: 2002-09-17 ( 217 days)
• Product Code: ILY
• Regulation Number: 890.5500
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

Temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.

Device Description

Sanidad Far-Infrared Mini Lamp, FI-3646

AI/ML Overview

This document is an FDA 510(k) clearance letter for the Sanidad Far-Infrared Mini Lamp, FI-3646. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory classifications, general controls, and compliance requirements, but it does not detail any performance studies conducted by the manufacturer for this specific device.

Therefore, I cannot provide the requested information based on the provided text. The document is strictly a regulatory approval notice, not a scientific study report.

Regulation Number and Section

§ 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.