Identity
- Trade Name
- Ergowave EUDAMEDErgowave Roller Massage Table FDA UDI
- Generic Name
- Traction table, line-powered FDA UDI
- Device Name
- Powered Tables EUDAMED
- Model / Reference
- EW9090 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850008449949 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850008449PoweredNQ EUDAMED
- Direct Marketing DI
- 00850008449949 EUDAMED
- FDA Product Code
- ISA 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
- 890.5660 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
Ergowave by Pivotal Health Solutions — 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 2d529464-e75b-42b2-9bab-1ca3b024cb5b 61 fields · synced Jun 18, 2026
- FDA UDI 41788ead-70a0-4758-a617-61b3c2a6774d 32 fields · synced May 30, 2026