510(k) Report

FDA applicant

Pivot Assist, LLC

Garfield Hts., OH1 decision2008–20080 recalls

FDA records 1 decision for Pivot Assist, LLC (Garfield Hts., OH) in 2008: 1 510(k) clearance. All are in product code INO (Chair, Positioning, Electric). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Pivot Assist, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Pivot Assist, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Pivot”

FDA records each applicant name separately; these may or may not be the same firm.