Identity
- Trade Name
- Assess Balance FDA UDI
- Generic Name
- Posturography system application software FDA UDI
- Model / Reference
- Version 7 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010129111 FDA UDI
- FDA Product Code
- KHX FDA UDI
- GMDN Term
- Posturography system application software 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Posturography system application software
Assess Balance by Balance Tracking Systems Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Posturography system application software.
- Kinesis Balance — KINESIS · Class I
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
- Balance Tracking Systems Incorporated
Sources (1)
- FDA UDI badb30f6-d00c-41a8-a8ca-2c550ca0d23d 33 fields · synced Jun 8, 2026