Shear Stress Therapeutics SST 3000

• K Number: K182163
• Device Name: Shear Stress Therapeutics SST 3000
• Manufacturer: Shear Stress Therapeutics, LLC
• Date Cleared: 2019-07-09 ( 333 days)
• Product Code: IPF
• Regulation Number: 890.5850
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Shear Stress Therapeutics SST 3000 can be used for the standard purposes of muscle stimulators:

• 1. Relaxation of muscle spasms
• 2. Prevention of retardation of disuse atrophy
• 3. Increasing local blood circulation
• 4. Muscle re-education
• 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• 6. Maintaining or increasing range of motion

Device Description

Not Found

AI/ML Overview

The provided text is a clearance letter from the FDA for a medical device called "Shear Stress Therapeutics SST 3000," a Powered Muscle Stimulator. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The letter focuses on the FDA's determination of substantial equivalence (510(k) clearance) to legally marketed predicate devices, the regulatory classification, and general controls provisions. It also includes the "Indications for Use" for the device, which are standard for muscle stimulators.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

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).