Identity
- Trade Name
- FDM-S System FDA UDI
- Generic Name
- Gait analysis system FDA UDI
- Device Name
- Platform system for pressure distribution measurement under the human feet, intended for the analysis of the static and dynamic loads, as well as the individual gait parameters. FDA UDI
- Model / Reference
- 01543010 FDA UDI
- Description
- Platform system for pressure distribution measurement under the human feet, intended for the analysis of the static and dynamic loads, as well as the individual gait parameters. FDA UDI
Identifiers
- Catalog Number
- NA FDA UDI
- Primary DI / UDI-DI
- B915015430101 FDA UDI
- FDA Product Code
- KHX FDA UDI
- GMDN Term
- Gait analysis system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.1575 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Gait analysis system
FDM-S System by zebris MEDICAL GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gait analysis system.
- Kinesis QTUG — KINESIS · Class I
- KneeKG system — Emovi Inc · Class II
- VICON — VICON MOTION SYSTEMS INC · Class II
- Qualisys Clinical System — Qualisys AB · Class II
- VICON — VICON MOTION SYSTEMS INC · Class II
- Kinesis Gait — KINESIS · Class I
- Digitsole Pro — DIGITSOLE · Class II
- VICON — VICON MOTION SYSTEMS INC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- zebris MEDICAL GmbH
Sources (1)
- FDA UDI 98599919-4e47-4c59-892e-5c341d937c2a 36 fields · synced Jun 8, 2026