READY-HEAT BLANKET

• K Number: K042145
• Device Name: READY-HEAT BLANKET
• Manufacturer: TECHTRADE LLC
• Date Cleared: 2004-09-17 ( 39 days)
• Product Code: KME
• Regulation Number: 880.6060
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

To provide warm relief

Device Description

Ready Heat™ blanket

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding the "Ready Heat™ Blanket." It primarily addresses regulatory approval and does not contain specific information about acceptance criteria or a study proving the device meets them.

Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence to predicate devices, not performance testing details.

Regulation Number and Section

§ 880.6060 Medical disposable bedding.

(a)
Identification. Medical disposable bedding is a device intended for medical purposes to be used by one patient for a period of time and then discarded. This generic type of device may include disposable bedsheets, bedpads, pillows and pillowcases, blankets, emergency rescue blankets, or waterproof sheets.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.