Identity
- Trade Name
- FRA510S EUDAMEDInBody FDA UDI
- Generic Name
- Biomechanical function analysis system, motion-tracking FDA UDI
- Device Name
- Ataxiagraph FDA UDI
- Model / Reference
- FRA510S EUDAMEDJ9 EUDAMEDFRA 510(s) FDA UDI
- Description
- Ataxiagraph FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809209590938 EUDAMEDFDA UDI
- Basic UDI-DI
- 880920959J9Z5 EUDAMED
- Direct Marketing DI
- 08809209590938 EUDAMED
- FDA Product Code
- GWW FDA UDI
- EMDN Code
- Z12140404 POSTUROGRAPHY SYSTEMS EUDAMED
- GMDN Term
- Biomechanical function analysis system, motion-tracking FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 882.1030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Fra510s by InBody Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880920959J9Z5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- InBody Co., Ltd.
- EUDAMED SRN
- KR-MF-000011833
- Authorised Representative
- InBody Europe B.V. NL-AR-000011789
Sources (2)
- EUDAMED 0531d1ac-aa1a-49c3-9771-a1875aac8731 61 fields · synced Jul 9, 2026
- FDA UDI d091613d-f953-45e8-83c5-51ec559abeef 35 fields · synced May 30, 2026