510(k) Report

FDA applicant

Berkline Corp.

Morristown, TN1 decision2002–20020 recalls

FDA records 1 decision for Berkline Corp. (Morristown, TN) in 2002: 1 510(k) clearance. All are in product code INO (Chair, Positioning, Electric). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Berkline Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Berkline Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Berkline Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • INOChair, Positioning, Electric1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K023521Easy LifeBerkline Corp. · 2002

The one decision as Berkline Corp. →