Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Powered Muscle Stimulator for Rehabilitation

• Date: May 12, 2010
• Source: www.fda.gov

This draft guidance document was developed as a special controls guidance for powered muscle stimulators that are indicated for rehabilitation. If proposed 21 CFR 890.5850(a) is finalized, a powered muscle stimulator for rehabilitation will be defined as an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes contacting the affected body area.

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