510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800716Substantially Equivalent

Orthotic Leg Gait Corrector Device

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

K800716 is the FDA 510(k) clearance record for ORTHOTIC LEG GAIT CORRECTOR DEVICE, a class I device, cleared for Ipos Luneburg on under FDA product code ITO (Twister, Brace Setting). FDA records list 8 510(k) clearances for Ipos Luneburg, from to . As of , FDA records show no recalls naming K800716.

Clearance record

Decision date
Received
(32 days to decision)
Product code
ITO Twister, Brace Setting
Regulation
21 CFR 890.3410
Device class
Class I
Review panel
Physical Medicine
Applicant
Ipos Luneburg 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ITO

Trailing 12 months

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

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