Identity
- Trade Name
- Ergostyle FX EUDAMEDFDA UDI
- Generic Name
- Traction table, line-powered FDA UDI
- Device Name
- Powered Tables EUDAMED
- Model / Reference
- ES5821 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850008449727 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850008449PoweredNQ EUDAMED
- Direct Marketing DI
- 00850008449727 EUDAMED
- FDA Product Code
- INQ FDA UDI
- EMDN Code
- V080603 TREATMENT, DIAGNOSIS AND MONITORING MEDICAL BEDS EUDAMED
- GMDN Term
- Traction table, line-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3760 FDA UDI
- Market of Registration
- France EUDAMED
- 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
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
Ergostyle FX by Pivotal Health Solutions, Inc. — 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 | 0850008449PoweredNQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pivotal Health Solutions
- EUDAMED SRN
- US-MF-000042753
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED eabc60f6-5990-455e-9a98-3c988c55bba2 61 fields · synced Jul 23, 2026
- FDA UDI dbc878e0-f46c-4fad-8adc-b818e6b08887 32 fields · synced May 30, 2026