Identity
- Trade Name
- Ease Cushion FDA UDI
- Generic Name
- Alternating-pressure chair cushion, reusable FDA UDI
- Model / Reference
- Gen 1 20x20 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010877401 FDA UDI
- FDA Product Code
- IMP FDA UDI
- GMDN Term
- Alternating-pressure chair cushion, reusable 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Alternating-pressure chair cushion, reusable
Ease Cushion by Ease Seating Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- APEX — Wellell Inc. · Class II
- APEX — Wellell Inc. · Class II
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
- Ease Seating Systems
Sources (1)
- FDA UDI 200da002-15c1-4ce7-9ce8-77b6af746087 32 fields · synced May 30, 2026