FDA.reportPublic FDA data

Biodex

Primary DI
00718175001486
Brand
Biodex
Company
SPORT MEDICAL TECHNOLOGY INC.
Model
950-148
Catalog number
950-148
Device description
CYCLE, UPPER BODY - CLINICAL PRO
Published
2023-08-02
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
ISDExerciser, Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1
ISDExerciser, MeasuringPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00718175001486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00718175001486007181750014867181750014860718175001486

GMDN Terms#

Term, Definition table
TermDefinition
Body flywheel exerciserAn exercise apparatus intended to strengthen several of the major muscle groups of the body (i.e., in the arms, legs, chest, back) through repetitive body motion against a flywheel. During the muscle contraction phase resistance is provided by the inertia of the flywheel, which is subsequently set spinning to provide resistance during the muscle lengthening phase. It typically consists of a floor-standing platform with a pulley, axle, and connection disc for the attachment of flywheel weights, with an assortment of harnesses, straps and grips. The device typically enables the performance of a wide variety of exercise motions including curls, presses, lunges and raises.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
145217304
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00718175002407Biostep 2, 100-240 VAC950-2402024-05-06
00718175006009Reactive Step Trainer 115V950-6002024-05-06
00718175001462Biodex950-146950-1462023-08-02
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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