FDA.reportPublic FDA data

Extension mattress

Primary DI
04527799700332
Brand
Extension mattress
Company
PARAMOUNT BED CO., LTD.
Model
KA-H704EU
Device description
Mattress for tall users who use an extension frame.
Published
2020-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNLBed, Ac-Powered Adjustable Hospital
IKYMattress, Flotation Therapy, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04527799700332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04527799700332045277997003324527799700332

GMDN Terms#

Term, Definition table
TermDefinition
Bed extensionA device intended to be use to increase the length of a bed.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690552500
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04527799706549A6 Electrical Hospital Bed with Digital ScalePA-H6D582025-12-01
04527799706556A6 Electrical Hospital Bed with Digital ScalePA-H6D5C2025-12-01
04527799706563A6 Electrical Hospital Bed with Digital ScalePA-H6D5A2025-12-01
04527799706570A6 Electrical Hospital Bed with Digital ScalePA-H6D5B2025-12-01
04527799706624A6 Electrical Hospital Bed with Digital ScalePA-H6D682025-12-01
04527799706631A6 Electrical Hospital Bed with Digital ScalePA-H6D6C2025-12-01
04527799706648A6 Electrical Hospital Bed with Digital ScalePA-H6D6A2025-12-01
04527799706655A6 Electrical Hospital Bed with Digital ScalePA-H6D6B2025-12-01
04527799706709A6 Electrical Hospital Bed with Digital ScalePA-H6D58X2025-12-01
04527799706716A6 Electrical Hospital Bed with Digital ScalePA-H6D5CX2025-12-01
04527799706723A6 Electrical Hospital Bed with Digital ScalePA-H6D5AX2025-12-01
04527799706730A6 Electrical Hospital Bed with Digital ScalePA-H6D5BX2025-12-01
04527799706785A6 Electrical Hospital Bed with Digital ScalePA-H6D68X2025-12-01
04527799706792A6 Electrical Hospital Bed with Digital ScalePA-H6D6CX2025-12-01
04527799706808A6 Electrical Hospital Bed with Digital ScalePA-H6D6AX2025-12-01
04527799706815A6 Electrical Hospital Bed with Digital ScalePA-H6D6BX2025-12-01
04527799707188A6 Electrical Hospital BedPA-H6C182025-12-01
04527799707195A6 Electrical Hospital BedPA-H6C1C2025-12-01
04527799707201A6 Electrical Hospital BedPA-H6C1A2025-12-01
04527799707218A6 Electrical Hospital BedPA-H6C1B2025-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H93352765Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2026-08-25
H93363822Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2026-08-25
00817012020229K-11KAP MEDICALIKY2026-08-21
06979878770312CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-08-21
06979878770329CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-08-21
06979878770336CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-08-21
06979878770343CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-08-21
06979878770350CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-08-21
06979878770367CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-08-21
00810055884414MATT 35X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884421MATT 35X80 ELITE 500-G LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
0081005588443835X80 ELITE-G 500 STR ZIP COV INC BAR,CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884445MATT 35X76 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884452MATT 42X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884469MATT 42X80 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884476MATT 35X80 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884483MATT 35X80 ELITE-G SW 500 STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884490MATT 35X80 BASIC STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884506MATT 35X76 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884513MATT 35X84 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
0081005588452035X84 ELITE-G 500 STR ZIP COV INC BAR,CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884537MATT 42X80 ELITE-G 600 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884544MATT 35X76 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884551MATT 36X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884568MATT 36X80 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884575MATT 35X80 ELITE-G 600 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884582MATT 35X76 ELITE-G SW 500 STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884599MATT 35X84 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884612MATT 42X80 ELITE-G SW 500 STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884636MATT 39X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16