510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842805Substantially Equivalent

Impuls 3, It Selector

Robert Bosch Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842805 is the FDA 510(k) clearance record for IMPULS 3, IT SELECTOR, a class II device, cleared for Robert Bosch Corp. on under FDA product code ISB (Stimulator, Muscle, Diagnostic). FDA records list 21 510(k) clearances for Robert Bosch Corp., from to . As of , FDA records show no recalls naming K842805.

Clearance record

Decision date
Received
(15 days to decision)
Product code
ISB Stimulator, Muscle, Diagnostic
Regulation
21 CFR 890.1850
Device class
Class II
Review panel
Physical Medicine
Applicant
Robert Bosch Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ISB

Trailing 12 months

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

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