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
K790299Substantially Equivalent

Forearm-Cane

Guardian Products Co., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790299 is the FDA 510(k) clearance record for FOREARM-CANE, a class I device, cleared for Guardian Products Co., Inc. on under FDA product code IPS (Cane). FDA records list 8 510(k) clearances for Guardian Products Co., Inc., from to . As of , FDA records show no recalls naming K790299.

Clearance record

Decision date
Received
(9 days to decision)
Product code
IPS Cane
Regulation
21 CFR 890.3075
Device class
Class I
Review panel
Physical Medicine
Applicant
Guardian Products Co., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IPS

Trailing 12 months

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

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