K Number
K142215
Manufacturer
Date Cleared
2014-11-07

(87 days)

Product Code
Regulation Number
890.5500
Panel
PM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Power Twin 21 is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "Power Twin 21." It primarily addresses the regulatory approval process and states that the device is substantially equivalent to a legally marketed predicate device.

Critically, this document does not contain any information about acceptance criteria for device performance, nor does it describe any study proving the device meets such criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory classification and compliance, not on performance studies or clinical trial results. Manufacturers typically submit performance data in their 510(k) premarket notification, but that data is not included in the FDA's clearance letter itself.

§ 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.