Wheelchair Cushion Seating
by Span-America Medical Systems, Inc. 111 variants
Ref EQ1616-04Model Wheelchair Cushion Seating
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number++H933WHEELCHAIRSEATINGNZ H933EQ161604 | Date13 Feb 2025 | StatusActive |
| United States | GUDID listing GUDID | NumberH933EQ161604 | Date12 Jul 2022 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Span-America
- Generic Name
- Gel-filled chair cushion
- Device Name
- Wheelchair Cushion Seating
- Model / Ref / Catalog
- Wheelchair Cushion Seating, EQ1616-04, EQUALIZER
- Description
- EQUALIZER 16X16 (P03436)
- Primary DI / UDI-DI
- H933EQ161604
- Basic UDI-DI
- ++H933WHEELCHAIRSEATINGNZ
- FDA Product Code
- KIC
- EMDN Code
- V080302 Patient positioning medical cushions
- GMDN Term
- Gel-filled chair cushion
- Device Class
- Class I
- Regulation Number
- 890.3175
- EU market of registration
- Norway
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | Wheelchair Cushion Seating EQ1616-04 | EQUALIZER |
Manufacturer details
- EUDAMED SRN
- US-MF-000002745
- Authorised representative
- Advena SRL IT-AR-000051131
Other devices from Span-America Medical Systems, Inc.
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No