FDA.reportPublic FDA data

AccelStim

Primary DI
18257200158706
Brand
AccelStim
Company
Orthofix US LLC
Model
654300-9005
Catalog number
4300 Casting Kit Small
Device description
Casting Kit Assembly, Small, Accessory, ACCELSTIM Model 4300
Published
2023-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LOFStimulator, Bone Growth, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOFStimulator, Bone Growth, Non-InvasiveUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18257200158706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1825720015870618257200158706

GMDN Terms#

Term, Definition table
TermDefinition
Bone growth ultrasonic stimulatorA mains electricity (AC-powered) device designed to accelerate bone formation (osteogenesis) through the application of ultrasound energy. It typically consists of a pulsed low-intensity ultrasound generator that includes a transducer probe and a retaining and alignment fixture for the probe. The device is typically used to promote healing of nonunion fractures; it is also used to speed the healing of fresh fractures.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(214)937-2718pemfcustomerservice@orthofix.com

Regulatory Flags#

DUNS number
927083808
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18257200066421Orthofix Proview70-23002016-07-14
18257200066438Orthofix Proview70-23012016-07-14
18257200066445Orthofix Proview70-23022016-07-14
18257200066452Orthofix Proview70-23032016-07-14
28257200066497Orthofix Proview70-23042016-07-14
00850071315226TrendDCT-0180DCT-01802026-04-25
00850071315264TrendDCT-3951DCT-39512026-04-25
00850071315295TrendDCT-6061T-2DCT-6061T-22026-04-25
00850071315301TrendDCT-6061T-3DCT-6061T-32026-04-25
00850071315332TrendDCT-6061S-2DCT-6061S-22026-04-25
00850071315356TrendDCT-6061S-4DCT-6061S-42026-04-25
00850071315370TrendDCT-1971-2DCT-1971-22026-04-25
00850071315387TrendDCT-1971-4DCT-1971-42026-04-25
00850071315400TrendDCT-908-RDCT-908-R2026-04-25
00850071315417TrendDCT-908-LDCT-908-L2026-04-25
00850071315448TrendDCT-200-RDCT-200-R2026-04-25
00850071315455TrendDCT-200-LDCT-200-L2026-04-25
00850071315509TrendVSL-747-LGVSL-747-LG2026-04-25
00850071315516TrendDCT-3960DCT-39602026-04-25
00850071315462TrendDCT-1516-RDCT-1516-R2026-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850047248107XstimXstim, IncLOF2026-04-08
00850047248008XstimXstim, IncLOF2024-08-16
10850047248005XstimXstim, IncLOF2024-08-16
00850047248015XstimXstim, IncLOF2024-08-16
00850047248022XstimXstim, IncLOF2024-08-16
00850047248039XstimXstim, IncLOF2024-08-16
00850047248046XstimXstim, IncLOF2024-08-16
00850047248053XstimXstim, IncLOF2024-08-16
00850047248060XstimXstim, IncLOF2024-08-16
00850047248077XstimXstim, IncLOF2024-08-16
00850047248084XstimXstim, IncLOF2024-08-16
00850047248091XstimXstim, IncLOF2024-08-16
18257200158713AccelStimOrthofix US LLCLOF2023-06-12
18257200158720AccelStimOrthofix US LLCLOF2023-06-12
08050040997336AccelstimIGEA SPALOF2022-11-04
08050040997299AccelstimIGEA SPALOF2022-08-30
08050040997305AccelstimIGEA SPALOF2022-08-30
08050040997312AccelstimIGEA SPALOF2022-08-30
08050040997329AccelstimIGEA SPALOF2022-08-30
08050040997213AccelStimIGEA SPALOF2022-07-14
M937710346601EXOGEN Metatarsal StrapBIOVENTUS LLCLOF2021-12-17
00850372007165ActaStim-S THERAGEN, LLCLOF2021-02-08
00850372007172ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007189ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007196ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007202ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007219ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007226ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007233ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007240ActaStim-STHERAGEN, LLCLOF2021-02-08