FDA device listing
Air mattress: B01/B02;T01,T02,T03,T04,T05,T06,T07,T08,T09,Air Mattress:S01,ACM01,ACM02,AFM-100,AFM-200, Air…
FDA device listing 1204394498 · XIAMEN SENYANG CO., LTD
Key facts
| Proprietary names | Air mattress: B01/B02;T01,T02,T03,T04,T05,T06,T07,T08,T09,Air Mattress:S01,ACM01,ACM02,AFM-100,AFM-200, Air Pump:P01S,P02,P06C,P06D,P08A,P08B,P08C,P08E,P08M,Air pump:P01,P03,P05,P06A,P06B,P08,TKS2012,TKS02,TKS03,TKS05,P09,anti-bedsore mattresses with pump,Full Alternating Pressure Pad System-LVA3058BLK,Full alternating Seat Cushion-CSH1084BLKFUL,MedAir |
|---|---|
| Owner/operator | XIAMEN SENYANG CO., LTD |
| Owner/operator number | 10042814 |
| Product codes | FNM |
| Device names | FNM - Mattress, Air Flotation, Alternating Pressure |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5550 |
| Review panels | General Hospital |
| Registered establishments | XIAMEN SENYANG CO., LTD |
| Establishment registrations | 3009955851 |
| FEI numbers | 3009955851 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database