510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912071Substantially Equivalent

Space(tm) 7500

F.M. Wiest USA, Inc., Oradell NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912071 is the FDA 510(k) clearance record for SPACE(TM) 7500, a class II device, cleared for F.M. Wiest USA, Inc. on under FDA product code IKN (Electromyograph, Diagnostic). FDA records list 12 510(k) clearances for F.M. Wiest USA, Inc., from to . As of , FDA records show no recalls naming K912071.

Clearance record

Decision date
Received
(60 days to decision)
Product code
IKN Electromyograph, Diagnostic
Regulation
21 CFR 890.1375
Device class
Class II
Review panel
Physical Medicine
Applicant
F.M. Wiest USA, Inc. 690 Kinderkamack Rd., 1st Floor, Oradell NJ
510(k) summary
Summary
Third party review
No

Clearances, product code IKN

Trailing 12 months

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

FDA records show no clearances under product code IKN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IKN, 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