510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860037Substantially Equivalent

Suspender Orthopedic Suspension Device

Comfortex, Inc., Winona MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860037 is the FDA 510(k) clearance record for SUSPENDER ORTHOPEDIC SUSPENSION DEVICE, a class I device, cleared for Comfortex, Inc. on under FDA product code HST (Apparatus, Traction, Non-Powered). FDA records list 4 510(k) clearances for Comfortex, Inc., from to . As of , FDA records show no recalls naming K860037.

Clearance record

Decision date
Received
(15 days to decision)
Product code
HST Apparatus, Traction, Non-Powered
Regulation
21 CFR 888.5850
Device class
Class I
Review panel
Orthopedic
Applicant
Comfortex, Inc. 420 Main St., Winona MN
Third party review
No

Clearances, product code HST

Trailing 12 months

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

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