510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K981822Substantially Equivalent

Drs System

Professional Distribution Systems, Inc., Boca Raton FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981822 is the FDA 510(k) clearance record for DRS SYSTEM, a class II device, cleared for Professional Distribution Systems, Inc. on under FDA product code ITH (Equipment, Traction, Powered). FDA records list one 510(k) clearance for Professional Distribution Systems, Inc. As of , FDA records show no recalls naming K981822.

Clearance record

Decision date
Received
(33 days to decision)
Product code
ITH Equipment, Traction, Powered
Regulation
21 CFR 890.5900
Device class
Class II
Review panel
Physical Medicine
Applicant
Professional Distribution Systems, Inc. 1160 S. Rogers Cir., #A, Boca Raton FL
510(k) summary
Summary
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