Skip to the page
Get started – free

Data / Medical devices / Stimulator, Bone Growth, Non-Invasive

Stimulator, Bone Growth, Non-Invasive (LOF): 17 FDA-registered makers in 5 countries

17 establishments in 5 countries are registered with the FDA to make Stimulator, Bone Growth, Non-Invasive (product code LOF, Class 2, 21 CFR 890.5870). 11 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on September 29, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
LOF
Device class
2
Regulation
890.5870
Medical specialty
Orthopedic

Makers by country

CountryMakers
United States13
Italy1
Canada1
China1
Cambodia1

Makers of Stimulator, Bone Growth, Non-Invasive

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Djo, LLCVista, CA, United StatesManufacturer1September 29, 2026200api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer1September 29, 2026200api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesManufacturer, Specification developer0300api.fda.gov
Ebi Patient Care, Inc.Guaynabo, PR, United StatesManufacturer0200api.fda.gov
Ebi, LLCParsippany, NJ, United StatesComplaint file establishment, Specification developer0210api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer0200api.fda.gov
Bioventus LLCDurham, NC, United StatesManufacturer, Specification developer0100api.fda.gov
Bioventus LLCCordova, TN, United StatesComplaint file establishment, Manufacturer0110api.fda.gov
Igea SPACarpi (MO) Modena, ItalyManufacturer0100api.fda.gov
Theragen, Inc.Jacksonville, FL, United StatesSpecification developer0100api.fda.gov
Xstim Inc.Irving, TX, United StatesComplaint file establishment, Specification developer0100api.fda.gov
Clearlake-Tech IncClear Lake, SD, United StatesContract manufacturer0000api.fda.gov
Creation Technologies LtdMississauga Ontario, CanadaContract manufacturer0000api.fda.gov
JKH Health Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Just Keep Healthy Co., Ltd.Samkkei Munichay District Kampong Speu, CambodiaContract manufacturer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
SEKO MedTec SolutionsOakdale, PA, United StatesContract manufacturer0000api.fda.gov

Updated September 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.