Eltrac 471

FDA 510(k) K151640 · Enraf-Nonius, B.V.

Substantially Equivalent

510(k) numberK151640

Submission

Device name
Eltrac 471
Applicant
Enraf-Nonius, B.V.
Rotterdam, NL
Received
June 18, 2015
Decision date
October 16, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
ITH – Equipment, Traction, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5900
Specialty
Physical Medicine

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Questions and answers

When was Eltrac 471 cleared by the FDA?

Eltrac 471 (K151640) received a 510(k) decision of Substantially Equivalent on October 16, 2015, 120 days after the submission was received.

What is the product code of K151640?

The FDA product code is ITH – Equipment, Traction, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5900.