FORTE, MODELS CPS 400 STIM, CPS 200 STIM

• K Number: K982828
• Device Name: FORTE, MODELS CPS 400 STIM, CPS 200 STIM
• Manufacturer: CHATTANOOGA GROUP, INC.
• Date Cleared: 1998-11-06 ( 87 days)
• Product Code: IPF , GZJ , LIH
• Regulation Number: 890.5850
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

For VMS, Russian, Monophasic Hi-Volt:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

For Microcurrent. Interferential and Premodulated:

• Symptomatic relief of chronic, intractable pain
• Management of pain associated with post-traumatic or post-operative conditions

Device Description

Not Found

AI/ML Overview

The provided text is a letter from the FDA regarding a 510(k) premarket notification for several medical devices. It does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment.

Therefore, I cannot provide the requested information. The document primarily confirms the substantial equivalence of the listed devices to pre-amendment devices and outlines regulatory obligations for the manufacturer.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).