Cleared Traditional

TENSCARE ULTIMA NMS/EMS

K023997 · Tenscare, Ltd. · Physical Medicine

Mar 2003

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K023997 is an FDA 510(k) clearance for the TENSCARE ULTIMA NMS/EMS, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Tenscare, Ltd. (Timperley, Cheshire, GB). The FDA issued a Cleared decision on March 3, 2003, 90 days after receiving the submission on December 3, 2002. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K023997 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 03, 2002
Decision Date	March 03, 2003
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF