Span-America The Topper
by Span-America Medical Systems, Inc. 15 variants
Span-America The Topper (R-MEM8436) is a low-air-loss bed (FDA Class II; FDA product code FNM, Mattress, Air Flotation, Alternating Pressure) made by Span-America Medical Systems, Inc., listed in FDA GUDID since 20 Jul 2022 (UDI-DI H933RMEM8436), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberH933RMEM8436 | Date20 Jul 2022 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Span-America
- Generic name
- Low-air-loss bed
- Model / Ref / Catalog
- The Topper, R-MEM8436
- Primary DI / UDI-DI
- H933RMEM8436
- FDA product code
- FNM
- GMDN term
- Low-air-loss bed
- Device class
- Class II
- Regulation number
- 880.5550
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code FNM (Mattress, Air Flotation, Alternating Pressure).
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- SIMPULSE by Kinetic Concepts, Inc.