510(k) Report

FDA applicant

Pivotal Health Solutions

Watertown, SD2 decisions2010–20141 recall

FDA records 2 decisions for Pivotal Health Solutions (Watertown, SD) from 2010 to 2014: 2 510(k) clearances. All are in product code ITH (Equipment, Traction, Powered). Its devices cite 3 predicates, 0 of them its own earlier devices. 1 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 Pivotal Health Solutions’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2010: 12014: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2010high 1 (2024) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Pivotal Health Solutions by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ITHEquipment, Traction, Powered2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K131983Itrac Cervical Traction SystemPivotal Health Solutions · 2014
  • K101889Decompression of Choice and Neuro Decompression DevicePivotal Health Solutions · 20101 recall

All 2 as Pivotal Health Solutions →

What has been recalled?

1 recall linked to its devices; the latest:

  • K101889Decompression Table Model E9011. This device applies cervical and/or lumbar…Apr 29, 2024Class II