510(k) Report

FDA applicant

Spinalight, Inc.

Woodstock, GA7 decisions1994–20181 recall

FDA records 7 decisions for Spinalight, Inc. (Woodstock, GA) from 1994 to 2018: 7 510(k) clearances. Most are in product codes LXM (Manipulator, Plunger-Like Joint) and INQ (Table, Powered). Its devices cite 1 predicate, 1 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 Spinalight, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Spinalight, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LXMManipulator, Plunger-Like Joint4decisions
  • INQTable, Powered2decisions
  • JFBTable, Physical Therapy, Multi Function1decision

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K001476Torque Instrument, Model 8500Spinalight, Inc. · 20001cites it
  • K946258Model 8000 Atlas C-1 Orthogonal Adjusting InstrumentSpinalight, Inc. · 19951cites it

What has FDA decided for it lately?

  • K172536Atlas Percussion Adjusting InstrumentSpinalight, Inc. · 2018
  • K001476Torque Instrument, Model 8500Spinalight, Inc. · 2000
  • K955540Hand Held Atlas InstrumentSpinalight, Inc. · 1996
  • K946258Model 8000 Atlas C-1 Orthogonal Adjusting InstrumentSpinalight, Inc. · 19951 recall
  • K945954Models 4100 and 4300 MultitherapySpinalight, Inc. · 1995
  • K933621Hilo TableSpinalight, Inc. · 1994
  • K933622Flexion Distraction TableSpinalight, Inc. · 1994

All 7 as Spinalight, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K946258Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed…Mar 6, 2013Class II