Cleared Traditional

K151640 - ELTRAC 471
(FDA 510(k) Clearance)

K151640 · Enraf-Nonius, B.V. · Physical Medicine

Oct 2015

Decision

120d

Days

Class 2

Risk

K151640 is an FDA 510(k) clearance for the ELTRAC 471. This device is classified as a Equipment, Traction, Powered (Class II — Special Controls, product code ITH).

Submitted by Enraf-Nonius, B.V. (Rotterdam, NL). The FDA issued a Cleared decision on October 16, 2015, 120 days after receiving the submission on June 18, 2015.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5900.

Submission Details

510(k) Number	K151640 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 2015
Decision Date	October 16, 2015
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF