FDA UDI
In Commercial Distribution
🇺🇸 United States
EvoWalk
DI: 00860011699309
·
Model: 1.0
·
Evolution Devices, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EvoWalk
- Primary DI
- 00860011699309
- Version / Model
- 1.0
- Company Name
- Evolution Devices, Inc.
- Labeler DUNS
- 116985408
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-06
- Public Version
- 1
- Public Version Date
- 2025-08-14
- Public Version Status
- New
- Public Device Record Key
- 0aa2c550-9d7c-4eba-b1d6-9f3fc73f8a19
Device Description
The EvoWalk 1.0 system is a wearable non-invasive functional electrical stimulation (FES) device intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways in the spinal cord), thus providing treatment for foot drop. EvoWalk 1.0 can be used in a healthcare facility and home settings.
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| GZI | Stimulator, Neuromuscular, External Functional | Neurology | 882.5810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35725 | Gait-enhancement electrical stimulation system, external | An assembly of devices that applies electrical stimuli to the lower extremity nerves (e.g., peroneal or femoral) or muscles (e.g., those that cause ankle dorsiflexion), to cause the muscles in the leg to contract, thus improving the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders. It typically includes electrodes and an external pulse generator (EPG), and may be incorporated into an external prosthesis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860011699309 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230997 | 000 |