510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K881681Substantially Equivalent

Cybex Back Testing and Rehabilitation System

Cybex, Ronkonkoma NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881681 is the FDA 510(k) clearance record for CYBEX BACK TESTING AND REHABILITATION SYSTEM, a class II device, cleared for Cybex on under FDA product code IKK (System, Isokinetic Testing And Evaluation). FDA records list 9 510(k) clearances for Cybex, from to . As of , FDA records show no recalls naming K881681.

Clearance record

Decision date
Received
(736 days to decision)
Product code
IKK System, Isokinetic Testing And Evaluation
Regulation
21 CFR 890.1925
Device class
Class II
Review panel
Physical Medicine
Applicant
Cybex 2100 Smithtown Ave., Ronkonkoma NY
Third party review
No

Clearances, product code IKK

Trailing 12 months

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

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