Identity
- Trade Name
- DMECare Solutions Solid Seat Insert FDA UDI
- Generic Name
- Wheelchair seat cushion FDA UDI
- Device Name
- Solid Seat Insert 18"x 16". Weight Capacity: 300 LB FDA UDI
- Model / Reference
- 13041-18 FDA UDI
- Description
- Solid Seat Insert 18"x 16". Weight Capacity: 300 LB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784304212 FDA UDI
- FDA Product Code
- IMP FDA UDI
- GMDN Term
- Wheelchair seat cushion 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wheelchair seat cushion
DMECare Solutions Solid Seat Insert by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wheelchair seat cushion.
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- NYOrtho Wheelchair Cushion Gel-Foam 22x20x4 — N.Y. ORTHOPEDIC USA, INC. · Class I
- Spex Limited — SPEX LIMITED · Class I
- Spex Limited — SPEX LIMITED · 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
- Dynarex Corp.
Sources (1)
- FDA UDI bf3383a5-1b24-4b08-b16b-6e66c68e2902 33 fields · synced Jun 8, 2026