Identity
- Trade Name
- Invacare® Silhouette® Cushion FDA UDI
- Generic Name
- Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible FDA UDI
- Device Name
- SILHOUETTE BACK COVER FDA UDI
- Model / Reference
- SO15 FDA UDI
- Description
- SILHOUETTE BACK COVER FDA UDI
Identifiers
- Catalog Number
- SO15 FDA UDI
- Primary DI / UDI-DI
- 00841447112020 FDA UDI
- FDA Product Code
- IMP FDA UDI
- GMDN Term
- Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3920 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
Invacare® Silhouette® Cushion by Invacare Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible.
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- DynaRide S 2 Wheelchair-18"x16" Seat w/ Detach Desk Arm FR — Dynarex Corp. · Class I
- Everest & Jennings — GF Health Products, Inc · Class I
- DynaRide S 3 Lite Wheelchair 20"x16"-18 Flip Desk Arm FR — Dynarex Corp. · Class I
- STRONGBACK — STRONGBACK MOBILITY USA, LLC · Class I
- Everest & Jennings — GF Health Products, Inc · Class I
- STRONGBACK — STRONGBACK MOBILITY USA, LLC · 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
- Invacare Corp.
Sources (1)
- FDA UDI f19af293-2f72-479b-bb91-bd759e291afd 35 fields · synced Jun 6, 2026