FDA.reportPublic FDA data

Biostep 2, 100-240 VAC

Primary DI
00718175002407
Brand
Biostep 2, 100-240 VAC
Company
SPORT MEDICAL TECHNOLOGY INC.
Model
950-240
Device description
950-240 Biostep 2, 100-240 VAC
Published
2024-05-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BXBExerciser, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00718175002407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00718175002407007181750024077181750024070718175002407

GMDN Terms#

Term, Definition table
TermDefinition
Bicycle ergometerA device intended to be used to provide a quantitative measurement of the rate at which work (energy) is performed by a muscle or group of muscles under controlled conditions. It is operated by a person using their legs, usually the patient, undergoing assessment, treatment, training, or rehabiltation and measures this related muscle activity at defined workloads.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
145217304
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00718175006009Reactive Step Trainer 115V950-6002024-05-06
00718175001462Biodex950-146950-1462023-08-02
00718175001486Biodex950-148950-1482023-08-02
00718175005606Sit2Stand950-560950-5602023-07-31
00718175004302VibroTactile950-4302023-07-19
00718175004807NxSTEP945-480945-4802019-05-15
00718175004845NxSTEP950-484950-4842019-05-15
00718175005705MOBILITY ASSIST950-570950-5702019-06-10
00718175004852NxSTEP950-485950-4852019-04-30
00718175000038BALANCE SD950-440950-4402018-06-30
00718175000045BALANCE SD950-441950-4412018-06-30
00718175000052BALANCE SD950-444950-4442018-06-30
00718175000120BIOSWAY 950-460950-4602018-06-30
00718175004005System 4 Pro850-000850-0002017-12-18
00718175004050MJS System 3 Upgrade850-820850-8202017-12-18
00718175004067MJS System 3 Upgrade850-822850-8222018-08-10
00718175004203System 4 Quick Set840-000840-0002017-12-18
00718175004401System 4 MVP852-000852-0002017-12-18
00718175005408Gait Trainer 3950-400950-4002018-04-15
00718175005415Gait Trainer 3950-401950-4012018-04-30

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Primary DI, Brand, Company table
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04560340091770Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091787Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091800Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091817Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
06976287180787Active Passive Trainer for Upper and Lower LimbsGuangzhou Longest Medical Technology Co., Ltd.BXB2026-04-14
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