FDA UDI
In Commercial Distribution
🇺🇸 United States
ZENO ELECTRONIC WALKWAY
DI: 00860252000704
·
Model: Platinum
·
Zenometrics LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ZENO ELECTRONIC WALKWAY
- Primary DI
- 00860252000704
- Version / Model
- Platinum
- Catalog Number
- Z418-220 ALL SIZES
- Company Name
- Zenometrics LLC
- Labeler DUNS
- 028456795
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-08
- Public Version
- 2
- Public Version Date
- 2021-10-15
- Public Version Status
- Update
- Public Device Record Key
- 8146c533-1e42-4900-854d-8bac76dae0fa
Device Description
The Zeno Electronic Walkway with PKMAS Software deliver Gait Analysis measurements that describe the performance, style, effectiveness and efficiency of walking without referring to its etiology.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| JFC | System, Pressure Measurement, Intermittent | Physical Medicine | 890.1600 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35757 | Gait analysis system | An assembly of mains electricity (AC-powered) devices and instruments intended to be used to study walking or running patterns. The device uses a platform/mat that measures ground reaction forces or relative pressures (e.g., foot pressure mapping), and/or uses cameras to determine knee, ankle, and hip joint movements and to measure forces and torques. It can be used to diagnose problems related to walking or running and to help plan corrective actions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860252000704 | GS1 |
Customer Contacts
- Phone
- 914-263-5987
- [email protected]