510(k) Report

FDA applicant

Theragun, Inc.

Los Angeles, CA3 decisions2021–20210 recalls

FDA records 3 decisions for Theragun, Inc. (Los Angeles, CA) in 2021: 3 510(k) clearances. Most are in product codes OHS (Light Based Over The Counter Wrinkle Reduction) and IRP (Massager, Powered Inflatable Tube). Since 2016 its 510(k)s took a median of 119 days from receipt to decision, against 162 for FDA’s reviews in the same codes and years. Its devices cite 4 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, general and plastic surgery panel, where it files most

How often FDA has decided Theragun, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2021

2021: 3
2021high 3 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Theragun, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Theragun, 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?

  • OHSLight Based Over The Counter Wrinkle Reduction1decision
  • IRPMassager, Powered Inflatable Tube1decision
  • NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 119 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 162 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 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.

  • K211745RecoveryAir PROTheragun, Inc. · 20213cite it
  • K212155TheraFace LEDTheragun, Inc. · 20212cite it

What has FDA decided for it lately?

  • K212155TheraFace LEDTheragun, Inc. · 2021
  • K211745RecoveryAir PROTheragun, Inc. · 2021
  • K212238TheraFace MicrocurrentTheragun, Inc. · 2021

All 3 as Theragun, Inc. →