N/A

• K Number: K970590
• Device Name: N/A
• Manufacturer: NORTH AMERICAN TECHNICAL SERVICES CORP.
• Date Cleared: 1997-06-13 ( 115 days)
• Product Code: ILY
• Regulation Number: 890.5500
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: K970590 , K970592

Intended Use

NotFound

Device Description

Health Zone/Healthy Vibes Mini Rechargeable Infrared Massager, Model KM-213H; Health Zone/Healthy Vibes Infrared Massager Set, Model KM-201

AI/ML Overview

This FDA 510(k) letter for the Health Zone/Healthy Vibes Mini Rechargeable Infrared Massager and Infrared Massager Set (models KM-213H and KM-201, respectively) does not contain the information requested about acceptance criteria or a study proving the device meets said criteria.

The letter is primarily a declaration of substantial equivalence to previously marketed predicate devices, which allows the manufacturer to market the new devices. It confirms that the devices are regulatory Class II and are subject to general controls.

Therefore, I cannot provide the detailed information requested in the prompt based on this document. The document primarily focuses on regulatory approval based on equivalence, not on specific performance metrics or studies.

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.