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Device Explorer · FDA GUDID · GMDN 35463

Patient-worn bone growth electromagnetic stimulator

A battery-powered, body-worn device designed to apply an electrical stimulus directly to bone to promote bone formation (i.e., osteogenesis). It is intended to generate an electromagnetic (EM) field (and its associated induced voltage effects) around a fractur

US‑registered devices155in commercial distribution
Companies5labelers on GUDID
Single‑use87%of device records
Sterile8%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Ebi, Llc7045%
Orthofix Us Llc5535%
Theragen, Llc117%
Xstim, Inc117%
Djo, Llc85%

Top labelers

CompanyDevicesShare
Ebi, Llc7045%
Orthofix Us Llc5535%
Theragen, Llc117%
Xstim, Inc117%
Djo, Llc85%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CMFBiomet OrthoPak Non-invasive Bone Growth StimulaBiomet SpinalPak Non-invasive Spine Fusion StimuBiomet SpinalPak / OrthoPakActaStim-SXstimBiomet EBI Bone Healing SystemBiomet Bone Healing SystemBiomet OrthoPak Non-invasive StimulatorSpF®-PLUS-Mini (60 uA/W)SpF®-PLUS-Mini (60 uA/M)EBI OsteoGen™ Implantable Bone Growth StimulatorSpF®-XL IIb Implantable Spinal Fusion StimulatorSpF XL IIb Implantable Spinal Fusion StimulatorEBI OsteoGen Implantable Bone Growth StimulatorSPINAL STIM

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
LOFStimulator, Bone Growth, Non-Invasive90
LOFStimulator, bone growth, non-invasive53
LOEStimulator, Invasive Bone Growth13
GXYElectrode, Cutaneous3

GMDN & GCC registration

  • GMDN code 35463 · non‑implantable
  • Single‑use 87% · sterile 8% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many patient-worn bone growth electromagnetic stimulator products are registered in the US?

155 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Patient-worn bone growth electromagnetic stimulator", from 5 companies. The largest labeler is Ebi, Llc with 45% of records.

Which FDA product codes apply?

LOF (Stimulator, Bone Growth, Non-Invasive), LOF (Stimulator, bone growth, non-invasive), LOE (Stimulator, Invasive Bone Growth), GXY (Electrode, Cutaneous)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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