510(k) Report

FDA applicant

Djo, LLC

Vista, CA14 decisions1994–20261 recall

FDA records 14 decisions for Djo, LLC (Vista, CA) from 1994 to 2026: 13 510(k) clearances and 1 original PMA approval. Most are in product codes IPF (Stimulator, Muscle, Powered) and NGX (Stimulator, Muscle, Powered, For Muscle…). Since 2016 its 510(k)s took a median of 108 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 9 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 Djo, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2009: 12012: 12013: 22014: 12015: 12016: 32017: 22020: 12026 (partial year): 1
2007high 3 (2016) · 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 — Djo, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • IPFStimulator, Muscle, Powered4decisions
  • NGXStimulator, Muscle, Powered, For Muscle Conditioning4decisions
  • JOWSleeve, Limb, Compressible3decisions
  • LOFStimulator, Bone Growth, Non-Invasive2decisions
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 108 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 113 days; 4 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 19 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 23 times; 9 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.

  • K170903Compex Wireless USADjo, LLC · 20174cite it
  • K143551Compex Wireless USADjo, LLC · 20154cite it
  • K153704StriveDjo, LLC · 20163cite it
  • K153696Chattanooga Revolution WirelessDjo, LLC · 20162cite it
  • K201653Compex Sport Elite 3.0Djo, LLC · 20202cite it
  • K170918Compex Sport EliteDjo, LLC · 20172cite it

What has FDA decided for it lately?

  • K262721Spinalogic Bone Growth StimulatorDjo, LLC · 2026
  • K201653Compex Sport Elite 3.0Djo, LLC · 2020
  • K170918Compex Sport EliteDjo, LLC · 2017
  • K170903Compex Wireless USADjo, LLC · 2017
  • K153704StriveDjo, LLC · 2016
  • K153696Chattanooga Revolution WirelessDjo, LLC · 2016
  • K153224VitalStim (R) Plus Electrotherapy SystemDjo, LLC · 2016
  • K143551Compex Wireless USADjo, LLC · 2015

All 14 as Djo, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K091700VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a…May 28, 2013Class II