DYNA T-2000 PHYSICAL THERAPY SYSTEM

• K Number: K955808
• Device Name: DYNA T-2000 PHYSICAL THERAPY SYSTEM
• Manufacturer: THERMIA, INC.
• Date Cleared: 1997-11-03 ( 682 days)
• Product Code: IMB
• Regulation Number: 890.5250
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

Not Found

Device Description

DYNA T-2000 Physical Therapy System

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called the DYNA T-2000 Physical Therapy System. It states that the device is substantially equivalent to legally marketed predicate devices.

However, this letter does not contain the information required to answer your questions about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of information is typically found in the 510(k) submission itself, often in sections detailing performance data and clinical studies, which are not part of this clearance letter.

Therefore, I cannot provide the requested details based solely on the provided text.

Regulation Number and Section

§ 890.5250 Moist steam cabinet.

(a)
Identification. A moist steam cabinet is a device intended for medical purposes that delivers a flow of heated, moisturized air to a patient in an enclosed unit. It is used to treat arthritis and fibrosis (a formation of fibrosis tissue) and to increase local blood flow.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.