FDA.reportPublic FDA data

NxSTEP

Primary DI
00718175004852
Brand
NxSTEP
Company
SPORT MEDICAL TECHNOLOGY INC.
Model
950-485
Catalog number
950-485
Device description
NxSTEP Unweighing System, 115VAC
Published
2019-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ITJWalker, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00718175004852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00718175004852007181750048527181750048520718175004852

GMDN Terms#

Term, Definition table
TermDefinition
Mobile gait rehabilitation system, harness-supportA mobile assembly of battery-powered devices designed to assist a patient with a walking/balance disability (neurological, muscular, cardiovascular, or orthopaedic in origin) to regain lost motor function, by enabling the patient to walk over ground (i.e., not on a treadmill) whilst supported from above. It consists of a mobile rigid framework on electronically-controlled wheels, a patient harness with suspension assembly, and motion sensors; the device senses patient movements and automatically follows the patient. The patient is supported overhead to assist rehabilitation and provide fall protection. It is intended to be used in a clinical setting under professional supervision.

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
00718175002407Biostep 2, 100-240 VAC950-2402024-05-06
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06977176610255BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
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