510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884787Substantially Equivalent

Acculite-Ppl 5

Medical Alignment Systems, Sandy UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884787 is the FDA 510(k) clearance record for ACCULITE-PPL 5, a class I device, cleared for Medical Alignment Systems on under FDA product code INE (Sling, Overhead Suspension, Wheelchair). FDA records list 3 510(k) clearances for Medical Alignment Systems, from to . As of , FDA records show no recalls naming K884787.

Clearance record

Decision date
Received
(70 days to decision)
Product code
INE Sling, Overhead Suspension, Wheelchair
Regulation
21 CFR 890.3910
Device class
Class I
Review panel
Physical Medicine
Applicant
Medical Alignment Systems 9160 S. 300 W., Bldg. 1,, Sandy UT
Third party review
No

Clearances, product code INE

Trailing 12 months

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

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