FDA.reportPublic FDA data

EKCOMED

Primary DI
00850000965140
Brand
EKCOMED
Company
Ekcomed, Inc.
Model
EKM-PCB00635
Catalog number
EKM-PCB00635
Device description
Patient Boot Pad Kit
Published
2024-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850000965140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000965140008500009651408500009651400850000965140

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, single-useA non-rigid device, typically a strap(s), band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-517-1833info@ekcomed.com

Regulatory Flags#

DUNS number
119213735
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000965003EKCOMEDEKM-SD937EKM-SD9372022-10-27
00850000965010EKCOMEDEKM-SR10BEKM-SR10B2022-10-27
00850000965027EKCOMEDEKM-CFM10559EKM-CFM105592022-10-27
00850000965034EKCOMEDEKM-CSD10573EKM-CSD105732022-10-27
00850000965041EKCOMEDEKM-SSS1606EKM-SSS16062022-10-27
00850000965058EKCOMEDEKM-TBC1644EKM-TBC16442022-10-27
00850000965065EKCOMEDEKM-DKP294EKM-DKP2942022-10-27
00850000965072EKCOMEDEKM-MCP401EKM-MCP4012022-10-27
00850000965089EKCOMEDEKM-SSS1606VEKM-SSS1606V2022-10-27
00850000965096EKCOMEDEKM-SMFM1064EKM-SMFM10642022-10-27
00850000965102EKCOMEDEKM-AD14407EKM-AD144072022-10-27
00850000965119EKCOMEDEKM-CFMA100EKM-CFMA1002022-10-27
00850000965126EKCOMEDEKM-SAN0195EKM-SAN01952022-10-27
00850000965133EKCOMEDEKM-PPR0634EKM-PPR06342022-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196413737MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-04-27
10080196413256MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413485MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413690MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
07613327632859SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327632866SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149810MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149827MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
G242SB03RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB07SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB12RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SS03DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB01RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB05SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB10RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS01DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS04DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS05DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS08DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS10DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS11DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS15DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
10197344161034MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-07-28
10197344158768MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-06-30
10197344100392MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-04-05
10080196413805MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-01-22