510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903532Substantially Equivalent

Unna-Sleeve(tm)

Aci Medical, LLC, Sun Valley CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903532 is the FDA 510(k) clearance record for UNNA-SLEEVE(TM), a class II device, cleared for Aci Medical, Inc. on under FDA product code LLK (Legging, Compression, Non-Inflatable). FDA records list 7 510(k) clearances for Aci Medical, Inc., from to . As of , FDA records show no recalls naming K903532.

Clearance record

Decision date
Received
(88 days to decision)
Product code
LLK Legging, Compression, Non-Inflatable
Regulation
21 CFR 880.5780
Device class
Class II
Review panel
General Hospital
Applicant
Aci Medical, Inc. 9249 Glenoaks Bl., Sun Valley CA
Third party review
No

Clearances, product code LLK

Trailing 12 months

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

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