Cleared Traditional

K003596 - SMITH & NEPHEW RESTIM (FDA 510(k) Clearance)

K003596 · Smith & Nephew, Inc. · Physical Medicine device

Jun 2001

Decision

197d

Days

Class 2

Risk

K003596 is an FDA 510(k) clearance for the SMITH & NEPHEW RESTIM. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).

Submitted by Smith & Nephew, Inc. (Germantown, US). The FDA issued a Cleared decision on June 6, 2001, 197 days after receiving the submission on November 21, 2000.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K003596 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 21, 2000
Decision Date	June 06, 2001
Days to Decision	197 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF