Electromagnetic Stimulator For Healthy Muscle Stimulation

SGT · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.5850

Classification

FDA Product Code: SGT
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 890.5850
Review panel: PM
Medical specialty: Physical Medicine
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

A device used for other than medical purposes to induce an electrical current to the body using a time-varying magnetic field to temporarily increase local blood flow and stimulate healthy muscles. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown