Identity
- Trade Name
- Qualisys Clinical System FDA UDI
- Generic Name
- Gait analysis system FDA UDI
- Device Name
- The Qualisys Clinical System is a camera and computer system used to quantify and graphically display human movement patterns for adults and children. It is intended to be used for movement analysis in the fields of gait analysis, rehabilitation, sports medicine and ergonomics. FDA UDI
- Model / Reference
- 1.5.0.408 FDA UDI
- Description
- The Qualisys Clinical System is a camera and computer system used to quantify and graphically display human movement patterns for adults and children. It is intended to be used for movement analysis in the fields of gait analysis, rehabilitation, sports medicine and ergonomics. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07300009074518 FDA UDI
- 510(k) Number
- K171547 FDA UDI
- FDA Product Code
- LXJ FDA UDI
- GMDN Term
- Gait analysis system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5360 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gait analysis system
Qualisys Clinical System by Qualisys AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Qualisys AB
Sources (1)
- FDA UDI bacb1fb7-9f07-46ae-aa1f-d882e9b3ce0f 35 fields · synced May 30, 2026