FDA.reportPublic FDA data

AirFloat Static Air Seat Cushion

Primary DI
00810006684117
Brand
AirFloat Static Air Seat Cushion
Company
PRIMO INC
Model
AF1919P
Catalog number
AF1919P
Device description
"AirFloat Static Air Seat Cushion (19""x19"") with pump"
Published
2021-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810006684114PackageGS112In Commercial Distribution
00810006684117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081000668411410810006684114
00810006684117008100066841178100066841170810006684117

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair seat cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair typically by improving posture, providing back and/or side support, compensating for seat height, relieving stress points, and providing pressure alleviation for the buttocks, lumbar region, and the legs, and/or by providing an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. This is a reusable device.

Regulatory Flags#

DUNS number
958758146
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810006680072Glide & Guide Turn Sheet GGS3660GGS36602019-02-27
00810006680089Glide & Guide Turn Sheet GGS3660TSGGS3660TS2019-02-27
00810006680096Glide & Guide Turn Sheet GGS5660GGS56602019-02-27
00810006680355Glide & Guide Turn Sheet Select GGS3660FGGS3660F2019-02-27
00810006680362Glide & Guide Turn Sheet Select GGS3660SSFGGS3660SSF2019-02-27
00810006680379Glide & Guide Turn Sheet GGS3660SSGGS3660SS2019-02-27
00810006680386Glide & Guide Turn Sheet Select GGS3660TSFGGS3660TSF2019-02-27
00810006680393Glide & Guide Turn Sheet GGS4460GGS44602019-02-27
00810006680409Glide & Guide Turn Sheet GGS4460SSGGS4460SS2019-02-27
00810006680416Glide & Guide Turn Sheet GGS4460TSGGS4460TS2019-02-27
00810006680423Glide & Guide Turn Sheet Select GGS5660FGGS5660F2019-02-27
00810006680430Glide & Guide Turn Sheet GGS5660SSGGS5660SS2019-02-27
00810006680447Glide & Guide Turn Sheet Select GGS5660SSFGGS5660SSF2019-02-27
00810006680454Glide & Guide Turn Sheet GGS5660TSGGS5660TS2019-02-27
00810006680461Glide & Guide Turn Sheet Select GGS5660TSFGGS5660TSF2019-02-27
00810006681574Glide & Guide Turn Sheet GGS3660PSGGS3660PS2019-02-27
00810006681598Glide & Guide Turn Sheet GGS5660PSGGS5660PS2019-02-27
00810006682366Synthetic Sheepskin Bed OverlaySS3024SS30242019-02-27
00810006682373Synthetic Sheepskin Bed OverlaySS3040SS30402019-02-27
00810006682380Synthetic Sheepskin Bed OverlaySS3060SS30602019-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00089904011503Action®ACTION PRODUCTS, INC.FMP2026-09-30
07333350181475Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350455873Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350647292Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350743918Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350775360Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350462161Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350529079Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350768249Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
00860015694713Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694720Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694737Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694744Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694751Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694768Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00089904011459Action®ACTION PRODUCTS, INC.FMP2026-07-23
00089904011435Action®ACTION PRODUCTS, INC.FMP2026-07-21
00089904011442Action®ACTION PRODUCTS, INC.FMP2026-07-21
00609271999336Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999343Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999374Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999381Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999473Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999480Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00089904011428Action®ACTION PRODUCTS, INC.FMP2026-07-17
00089904011411Action®ACTION PRODUCTS, INC.FMP2026-07-06
00816299013337HoverMatt PROSWedgeHovertech InternationalFMP2026-07-06
00089904011404Action®ACTION PRODUCTS, INC.FMP2026-06-08
00505627930841Repose Flex Large x10 &Pump x1Frontier Therapeutics IncFMP2026-06-05
05056279308434Repose Flex Large x1 & Pump x1Frontier Therapeutics IncFMP2026-06-05