Identity
- Trade Name
- Mölnlycke® Static Air Boots FDA UDI
- Generic Name
- Air-filled chair cushion FDA UDI
- Device Name
- Bariatric Seat Cushion FDA UDI
- Model / Reference
- 1400108 FDA UDI
- Description
- Bariatric Seat Cushion FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07323190273843 FDA UDI
- FDA Product Code
- FMP FDA UDI
- GMDN Term
- Air-filled chair cushion FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6450 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Air-filled chair cushion
Mölnlycke® Static Air Boots by Mölnlycke Health Care AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-filled chair cushion.
- ROHO LOW PROFILE Single Compartment Cushion — Roho, Inc. · Class I
- Varilite — Cascade Designs, Inc. · Class I
- Varilite — Cascade Designs, Inc. · Class I
- Star — KI MOBILITY, LLC · Class I
- Star — KI MOBILITY, LLC · Class I
- ROHO QUADTRO SELECT HIGH PROFILE Cushion — Roho, Inc. · Class I
- WAFFLE — EHOB, INC. · Class I
- ROHO MID PROFILE Single Compartment Cushion — Roho, Inc. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mölnlycke Health Care AB
Sources (1)
- FDA UDI ab3bd25b-7be6-48b2-a004-a5a4376e9db6 35 fields · synced Jun 1, 2026