510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K941033Substantially Equivalent

Physio Hab

Longo Industries, Pueblo CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941033 is the FDA 510(k) clearance record for PHYSIO HAB, a class II device, cleared for Longo Industries on under FDA product code ISD (Exerciser, Measuring). FDA records list one 510(k) clearance for Longo Industries. As of , FDA records show no recalls naming K941033.

Clearance record

Decision date
Received
(360 days to decision)
Product code
ISD Exerciser, Measuring
Regulation
21 CFR 890.5360
Device class
Class II
Review panel
Physical Medicine
Applicant
Longo Industries 1800 Liberty Dr., Pueblo CO
510(k) summary
Statement
Third party review
No

Clearances, product code ISD

Trailing 12 months

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

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