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
K051938Substantially Equivalent

Triton/tru-Trac/tx Traction Devices

Chattanooga Group, Inc., Hixson TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K051938 is the FDA 510(k) clearance record for TRITON/TRU-TRAC/TX TRACTION DEVICES, a class II device, cleared for Chattanooga Group on under FDA product code ITH (Equipment, Traction, Powered). FDA records list 81 510(k) clearances for Chattanooga Group, from to . As of , FDA records show no recalls naming K051938.

Clearance record

Decision date
Received
(65 days to decision)
Product code
ITH Equipment, Traction, Powered
Regulation
21 CFR 890.5900
Device class
Class II
Review panel
Physical Medicine
Applicant
Chattanooga Group 4717 Adams Rd., Hixson TN
510(k) summary
Statement
Third party review
No

Clearances, product code ITH

Trailing 12 months

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

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