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
K081053Substantially Equivalent

Pivot Assist

Pivot Assist, LLC, Garfield Hts. OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081053 is the FDA 510(k) clearance record for PIVOT ASSIST, a class II device, cleared for Pivot Assist, LLC on under FDA product code INO (Chair, Positioning, Electric). FDA records list one 510(k) clearance for Pivot Assist, LLC. As of , FDA records show no recalls naming K081053.

Clearance record

Decision date
Received
(178 days to decision)
Product code
INO Chair, Positioning, Electric
Regulation
21 CFR 890.3110
Device class
Class II
Review panel
Physical Medicine
Applicant
Pivot Assist, LLC 9335 Mccracken Blvd., Garfield Hts. OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code INO

Trailing 12 months

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

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