510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852398Substantially Equivalent

Vector Bar Suspension/traction Unit

Powlan Manufacturing Co., Lafayette CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852398 is the FDA 510(k) clearance record for VECTOR BAR SUSPENSION/TRACTION UNIT, a class I device, cleared for Powlan Manufacturing Co. on under FDA product code ILZ (Accessories, Traction). FDA records list one 510(k) clearance for Powlan Manufacturing Co. As of , FDA records show no recalls naming K852398.

Clearance record

Decision date
Received
(67 days to decision)
Product code
ILZ Accessories, Traction
Regulation
21 CFR 890.5925
Device class
Class I
Review panel
Physical Medicine
Applicant
Powlan Manufacturing Co. One Chapel Dr., Lafayette CA
Third party review
No

Clearances, product code ILZ

Trailing 12 months

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

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