Identity
- Trade Name
- Posture-Mate FDA UDI
- Generic Name
- Wheelchair seat cushion FDA UDI
- Device Name
- 2218-H Posture-Mate HB 16" Head Cushion only for wheelchair FDA UDI
- Model / Reference
- HB 16" Head Cushion only FDA UDI
- Description
- 2218-H Posture-Mate HB 16" Head Cushion only for wheelchair FDA UDI
Identifiers
- Catalog Number
- 2218-H FDA UDI
- Primary DI / UDI-DI
- 00850016369611 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wheelchair seat cushion
Posture-Mate by Immersus Health Company, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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
- Immersus Health Company, LLC
Sources (1)
- FDA UDI 678a4e45-4a84-4a37-9e28-e7cf9d63cacb 35 fields · synced Jun 8, 2026