510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K812902Substantially Equivalent

Acupress Vibrator

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

K812902 is the FDA 510(k) clearance record for ACUPRESS VIBRATOR, a class I device, cleared for Eicona Corp. on under FDA product code IRO (Vibrator, Therapeutic). FDA records list one 510(k) clearance for Eicona Corp. As of , FDA records show no recalls naming K812902.

Clearance record

Decision date
Received
(25 days to decision)
Product code
IRO Vibrator, Therapeutic
Regulation
21 CFR 890.5975
Device class
Class I
Review panel
Physical Medicine
Applicant
Eicona Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IRO

Trailing 12 months

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

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