510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K942563Substantially Equivalent

Elite Biofeedback

Abbott Medical, South Burlington VT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942563 is the FDA 510(k) clearance record for ELITE BIOFEEDBACK, a class II device, cleared for Laborie Medical Technologies, Ltd. on under FDA product code HIR (Perineometer). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K942563.

Clearance record

Decision date
Received
(371 days to decision)
Product code
HIR Perineometer
Regulation
21 CFR 884.1425
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Laborie Medical Technologies, Ltd. 7 Green Tree Dr., South Burlington VT
510(k) summary
Statement
Third party review
No

Clearances, product code HIR

Trailing 12 months
1 clearance under product code HIR in the twelve months to November 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIR, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260