FDA.reportPublic FDA data

Stretch-Glide

Primary DI
04527799700158
Brand
Stretch-Glide
Company
PARAMOUNT BED CO., LTD.
Model
KE-798SGA
Device description
Bed mattress.
Published
2020-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IKYMattress, Flotation Therapy, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04527799700158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04527799700158045277997001584527799700158

GMDN Terms#

Term, Definition table
TermDefinition
Basic bed mattressA large, durable, fabric case filled with a resilient material designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep. The device provides no special therapeutic effect.

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
H93383478Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2026-07-13
00887761010901Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
00887761010918Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
00887761010925Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
05059441461654TherarestArjohuntleigh ABIKY2026-02-10
00810178885084ViveVIVE HEALTH LLCIKY2026-02-02
00810178885091ViveVIVE HEALTH LLCIKY2026-02-02
H93353893Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-12-01
08592654851067Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
08592654851074Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
08592654851081Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
00841447115175Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115182Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115199Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115205Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
05056147701497Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701503Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701510Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701527Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701534Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701541Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701558Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701565Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701572Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701589Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701596Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701602Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
H93331629Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-09-04
H93313584Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-09-04
H93335834Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-08-04