FDA UDI
In Commercial Distribution
🇺🇸 United States
AMBLE
DI: 00860005350827
·
Model: 0644
·
Nextstep Robotics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AMBLE
- Primary DI
- 00860005350827
- Version / Model
- 0644
- Company Name
- Nextstep Robotics, Inc.
- Labeler DUNS
- 080658816
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-29
- Public Version
- 1
- Public Version Date
- 2025-10-07
- Public Version Status
- New
- Public Device Record Key
- 84f9edd3-d420-479d-a49b-c2c4b228ea35
Device Description
AMBLE is a body-worn powered exerciser intended to restore ankle function during walking.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BXB | Exerciser, Powered | Physical Medicine | 890.5380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58943 | Programmable ambulation exoskeleton, clinical | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860005350827 | GS1 |
Customer Contacts
- Phone
- 4438693518
- [email protected]