Cleared Special

K033544 - ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607 (FDA 510(k) Clearance)

K033544 · Everyway Medical Instruments Co.,Ltd · Physical Medicine device

Dec 2003

Decision

30d

Days

Class 2

Risk

K033544 is an FDA 510(k) clearance for the ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).

Submitted by Everyway Medical Instruments Co.,Ltd (Alpharetta, US). The FDA issued a Cleared decision on December 10, 2003, 30 days after receiving the submission on November 10, 2003.

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

Submission Details

510(k) Number	K033544 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 10, 2003
Decision Date	December 10, 2003
Days to Decision	30 days
Submission Type	Special
Review Panel	Physical Medicine (PM)
Summary	Summary PDF