FDA.reportPublic FDA data

K-11

Primary DI
00817012020229
Brand
K-11
Company
KAP MEDICAL
Model
K-11
Catalog number
K-11
Device description
FOAM MATTRESS, FLOTATION THERAPY, NON-POWERED
Published
2026-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00817012020229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817012020229008170120202298170120202290817012020229

GMDN Terms#

Term, Definition table
TermDefinition
Foam bed mattressA large, durable, fabric case filled with foam, which may be segmented/compartmentalised, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. It may contain weight-distribution air cells. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
951-340-4360sales@kapmedical.com

Regulatory Flags#

DUNS number
135241342
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817012031867K-6oem AIRE-TURN ASSISTK-6oem VersaAir Bari Alt-TurnK-6oem VersaAir Bari Alt-Turn2026-05-29
00817012031874K-2oem ALT-AIRE+K-2oem VersaAir Bari AltK-2oem VersaAir Bari Alt2026-05-29
00817012031904K-4 D3XK-4-NS-AVLK-4-NS-AVL2026-05-29
00817012031911K-4 D3XK-4-NS-BB-AVLK-4-NS-BB-AVL2026-05-29
00817012031881K-0 ECO-ZONEK-0-CONV-X-MSK-0-CONV-X-MS2026-05-26
00817012031898K-0 ECO-ZONEK-0-RTC-CONV-X-MSK-0-RTC-CONV-X-MS2026-05-26
00817012031850K-6 TURN-ZONEU-K-6-MSU-K-6-MS2026-01-16
00817012031812K-2oem ALT-AIRE+K-2oem-AU-X-MS-D-8K-2oem-AU-X-MS-D2025-10-10
00817012031829K-6oem AIRE-TURN ASSIST K-6oem-AU-X-MS-D-8K-6oem-AU-X-MS-D-82025-10-10
00817012031836K-4oem AIRE-FLOATK-4oem-EU-X-MS-D-8K-4oem-EU-X-MS-D-82025-10-10
00817012031843K-Zoem EZ-TURNK-Zoem-EU-X-MS-D-8K-Zoem-EU-X-MS-D-82025-10-10
00817012031805K-4oem AIRE-FLOATMATRIX-ALALMS8MATRIX-ALALMS82025-10-01
00817012031775K-6oem AIRE-TURN ASSIST K-6oem-X-MS-D-8K-6oem-X-MS-D-82025-09-26
00817012031782K-6oem AIRE-TURN ASSIST K-6oem-EU-X-MS-D-8K-6oem-EU-X-MS-D-82025-09-26
00817012031799K-6oem AIRE-TURN ASSIST K-6oem-UK-X-MS-D-8K-6oem-UK-X-MS-D-82025-09-26
00817012031744K-2oem ALT-AIRE+K-2oem-X-MS-D-8K-2oem-X-MS-D-82025-09-19
00817012031751K-2oem ALT-AIRE+K-2oem-EU-X-MS-D-8K-2oem-EU-X-MS-D-82025-09-19
00817012031768K-2oem ALT-AIRE+K-2oem-UK-X-MS-D-8K-2oem-UK-X-MS-D-82025-09-19
00817012031720K-4oem AIRE-FLOATMATRIX-ALALMS8X84MATRIX-ALALMS8X842025-09-05
00817012031737K-6 TURN-ZONEK-6-MS-84-DK-6-MS-84-D2025-09-04

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
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
00810055884643MATT 42X80 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884674MATT 36X80 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884681MATT 42X84 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884704MATT 42X84 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884711MATT 35X84 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
0081005588472836X80 ELITE-G 500 STR ZIP COV INC BAR,CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884735MATT 35X84 ELITE-G SW 500 STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16