FDA UDI
In Commercial Distribution
🇺🇸 United States
ReStore
DI: 00860001744507
·
Model: 50-40-0001
·
REWALK ROBOTICS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ReStore
- Primary DI
- 00860001744507
- Version / Model
- 50-40-0001
- Company Name
- REWALK ROBOTICS LTD
- Labeler DUNS
- 533320867
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-16
- Public Version
- 1
- Public Version Date
- 2019-10-24
- Public Version Status
- New
- Public Device Record Key
- 58b3baf7-e553-490e-a338-ec02cc3dfb42
Device Description
The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| PHL | Powered Exoskeleton | Physical Medicine | 890.3480 | 2 |
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 | 00860001744507 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190337 | 000 |