510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151640Substantially Equivalent

Eltrac 471

Enraf-Nonius B.V., Rotterdam, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151640 is the FDA 510(k) clearance record for ELTRAC 471, a class II device, cleared for Enraf-Nonius, B.V. on under FDA product code ITH (Equipment, Traction, Powered). FDA records list 5 510(k) clearances for Enraf-Nonius, B.V., from to . As of , FDA records show no recalls naming K151640.

Clearance record

Decision date
Received
(120 days to decision)
Product code
ITH Equipment, Traction, Powered
Regulation
21 CFR 890.5900
Device class
Class II
Review panel
Physical Medicine
Applicant
Enraf-Nonius, B.V. Varseweg 127, Rotterdam, NL
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code ITH

Trailing 12 months

FDA records hold no clearances under product code ITH in the trailing twelve months.

FDA records show no clearances under product code ITH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ITH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260