Identity
- Trade Name
- Decompression Table EUDAMEDDecompression of Choice FDA UDI
- Generic Name
- Programmable powered traction system FDA UDI
- Device Name
- DOC Decompression Table EUDAMEDswing arm decompression table, 230V FDA UDI
- Model / Reference
- E9014 EUDAMEDFDA UDI
- Description
- swing arm decompression table, 230V FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852753008914 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00852753008914 EUDAMED
- FDA Product Code
- ITH FDA UDI
- EMDN Code
- Z12130201 TRACTION BEDS EUDAMED
- GMDN Term
- Programmable powered traction system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5900 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Decompression Table by Pivotal Health Solutions, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00852753008914 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 c1e5feb5-a977-46d4-a12e-1ee6fb8d2f2d 61 fields · synced Jun 18, 2026
- FDA UDI c29ae5a2-a528-4a3a-84d3-170488d6caf0 33 fields · synced May 30, 2026