FDA.reportPublic FDA data

ActaStim-S

Primary DI
00850372007240
Brand
ActaStim-S
Company
THERAGEN, LLC
Model
1101-0000
Catalog number
1101-0000
Device description
ActaStim-S Spine Fusion Stimulator System
Published
2021-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P190030000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190030000ActaStim-S Spine Fusion StimulatorTheragen, Inc.2020-12-09LOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850372007240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850372007240008503720072408503720072400850372007240

GMDN Terms#

Term, Definition table
TermDefinition
Patient-worn bone growth electromagnetic stimulatorA 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 fracture or fusion site; it is not intended to apply an electric current directly to the body. The device is used as an alternative to bone grafting for non-union fractures (a condition in which the ends of a fractured bone fail to unite), and as a spinal fusion adjunct in treating degenerative vertebral diseases. It is also known as an osteogenesis stimulator.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1060 millibar
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure700 millibar1060 millibar
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-901-5667help@actastim.com

Regulatory Flags#

DUNS number
080028759
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850372007158Neurotech Plus0439-50082019-07-22
00850372007004Neurotech Kneehab0412-50012016-09-16
00850372007011Neurotech Aviva0281-50002016-09-16
00850372007028Neurotech Kneehab0421-50302016-09-16
00850372007035Neurotech Kneehab0421-50322016-09-16
00850372007042Neurotech Kneehab0421-50382016-09-16
00850372007059Neurotech Kneehab0421-50402016-09-16
00850372007066Neurotech Kneehab0426-33000426-33022016-09-16
00850372007073Neurotech Recovery Back0431-50042016-09-16
00850372007080Neurotech Recovery Back0431-50062016-09-16
00850372007097Neurotech Plus0439-50062016-09-16
00850372007103Neurotech Aviva0458-50002016-09-16
00850372007141Neurotech Kneehab0411-50382016-12-05
00850372007110Neurotech Kneehab1230-33042016-09-16
00850372007127Neurotech Kneehab1230-33082016-09-16
00850372007165ActaStim-S 1101-00011101-00012021-02-08
00850372007172ActaStim-S1101-00021101-00022021-02-08
00850372007189ActaStim-S1101-00071101-00072021-02-08
00850372007196ActaStim-S1101-00061101-00062021-02-08
00850372007202ActaStim-S4101-00004101-00002021-02-08

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
18257200158706AccelStimOrthofix US LLCLOF2023-06-12
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