Cleared Traditional

K024258 - NEUROTECH KNEEHAB (FDA 510(k) Clearance)

K024258 · Bio-Medical Research, Ltd. · Physical Medicine device

Mar 2005

Decision

802d

Days

Class 2

Risk

K024258 is an FDA 510(k) clearance for the NEUROTECH KNEEHAB. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).

Submitted by Bio-Medical Research, Ltd. (Galway, IE). The FDA issued a Cleared decision on March 4, 2005, 802 days after receiving the submission on December 23, 2002.

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

Submission Details

510(k) Number	K024258 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 23, 2002
Decision Date	March 04, 2005
Days to Decision	802 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF