FDA UDI
In Commercial Distribution
🇺🇸 United States
MyndStep
DI: 00692520001027
·
Model: MyndStep Foot Drop Stimulator
·
MyndTec Inc
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MyndStep
- Primary DI
- 00692520001027
- Version / Model
- MyndStep Foot Drop Stimulator
- Catalog Number
- 800102
- Company Name
- MyndTec Inc
- Labeler DUNS
- 203019245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-16
- Public Version
- 2
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 0a7a6478-b624-46d8-9b59-8235ee95faad
Device Description
MyndStep is a wearable foot drop device, which comprises by stimulator unit, MyndStep APP, electrode lead wire, electrodes and leg brace. It can control the timing and duration of the stimulation by tracing the angle during walking. It uses FES (functional electrical stimulation) to treat and improve the patient's foot drop to help the patient improve their walking ability.
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 Safe
- 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 |
|---|---|---|---|---|
| GZI | Stimulator, Neuromuscular, External Functional | Neurology | 882.5810 | 2 |
| IPF | Stimulator, Muscle, Powered | Physical Medicine | 890.5850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46573 | Physical therapy transcutaneous neuromuscular electrical stimulation system | An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00692520001027 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202110 | 000 |