510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010096Substantially Equivalent

Multi Care Therapeutic Vibrator

Multicept, ApS., Hoersholm, DK / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K010096 is the FDA 510(k) clearance record for MULTI CARE THERAPEUTIC VIBRATOR, a class II device, cleared for Multicept A/S on under FDA product code KXQ (Vibrator For Therapeutic Use, Genital). FDA records list 3 510(k) clearances for Multicept A/S, from to . As of , FDA records show no recalls naming K010096.

Clearance record

Decision date
Received
(53 days to decision)
Product code
KXQ Vibrator For Therapeutic Use, Genital
Regulation
21 CFR 884.5960
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Multicept A/S Lyngsoe Alle 3,1, Hoersholm, DK
510(k) summary
Statement
Third party review
No

Clearances, product code KXQ

Trailing 12 months

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

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