510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K885343Substantially Equivalent

Standex

Alt, Inc., Redwood Falls MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885343 is the FDA 510(k) clearance record for STANDEX, a class I device, cleared for Alt, Inc. on under FDA product code ION (Exerciser, Non-Measuring). FDA records list one 510(k) clearance for Alt, Inc. As of , FDA records show no recalls naming K885343.

Clearance record

Decision date
Received
(124 days to decision)
Product code
ION Exerciser, Non-Measuring
Regulation
21 CFR 890.5370
Device class
Class I
Review panel
Physical Medicine
Applicant
Alt, Inc. 913 S. Washington, Redwood Falls MN
Third party review
No

Clearances, product code ION

Trailing 12 months

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

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