FDA.reportPublic FDA data

AlterG Anti-Gravity Treadmill

Primary DI
00850022788277
Brand
AlterG Anti-Gravity Treadmill
Company
Alterg, Inc.
Model
Shorts, Standard Lightweight-Lateral 3XS
Device description
Accessory, AlterG Shorts
Published
2022-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00850022788277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022788277008500227882778500227882770850022788277

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic-support treadmillA mains electricity (AC-powered) device intended to create an anti-gravity effect to facilitate standing and in-place walking or running of a patient with a lower extremity injury/disorder during rehabilitation; it may also be used for obesity weight reduction and to help improve cardiovascular fitness. It consists of a speed-regulated treadmill (an endless, shock-absorbing rubber belt rotating on rollers); an air-inflatable chamber intended to encircle the patient’s lower body to provide pressure for weight support; an operator control unit to regulate treadmill speed/elevation and air-pressure weight support level; and side-mounted rails for the patient to hold for stabilization.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
614284649
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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