FDA.reportPublic FDA data

AMBLE

Primary DI
00860005350827
Brand
AMBLE
Company
Nextstep Robotics, Inc.
Model
0644
Device description
AMBLE is a body-worn powered exerciser intended to restore ankle function during walking.
Published
2025-09-29
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
BXBExerciser, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005350827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005350827008600053508278600053508270860005350827

GMDN Terms#

Term, Definition table
TermDefinition
Programmable ambulation exoskeleton, clinicalA battery-powered, pre-programmed, lower-limb orthosis system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function by manipulating the legs through a normal walking pattern during ambulation. The system includes an exoskeleton structure made of metal with electric motors, mechanical actuators, and sensors for feedback; it is typically strapped to the legs over clothing. It is intended for multiple-patient use, in a controlled clinical setting (e.g., gait lab, rehabilitation centre) under healthcare professional supervision.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4438693518support@nextsteprobo.com

Regulatory Flags#

DUNS number
080658816
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

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Primary DI, Brand, Company table
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04560340091800Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091817Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.BXB2026-04-22
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