FDA.reportPublic FDA data

E.M Adams co, inc.

Primary DI
10840200304846
Brand
E.M Adams co, inc.
Company
E.M. ADAMS, INC.
Model
3083-1
Device description
HEEL & ELBOW PROTECTOR
Published
2021-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
50840200304837PackageGS16In Commercial Distribution
10840200304846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5084020030483750840200304837
1084020030484610840200304846

GMDN Terms#

Term, Definition table
TermDefinition
Heel protectorA device that is designed to be worn over the foot to provide a cushion to protect the heel from friction against surfaces and knocks against objects; the toes will protrude and not be protected. It is typically made from soft padded materials and is held in place with bands or straps around the foot or the foot can be slid into it like a sock. It is typically used by persons that have tendencies for skin sores on their heels, are bedridden, or prone to lack of control with their legs causing injury to the heels. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(772)461-0532EMADAMS@EMADAMSCO.COM

Regulatory Flags#

DUNS number
001403807
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50840200325580E.M. Adams Co Inc14-70809JK-12023-11-21
50840200325566E.M. Adams Co, Inc114-A3609-12023-11-17
50840200301072E.M. Adams Co Inc114-A11341-12023-10-31
10840200325551E.M. Adams Co Inc114-31613-12023-10-31
50840200325528E.M. Adams Co, Inc.14-3497-12023-10-20
50840200325443E.M. Adams co, inc.EP30405L-12023-06-20
50840200325313E.M. Adams Company14-3390-12022-08-18
50840200313525E.M. ADAMS CO, INC26-0615XL-12022-07-17
50840200313549E.M. ADAMS CO, INC26-0615XXL-12022-07-17
50840200313563E.M. ADAMS CO, INC26-0615XXXL-12022-07-17
50840200313587E.M. ADAMS CO, INC26-0615XXXXL-12022-07-17
50840200313624E.M. ADAMS CO, INC26-0644-12022-07-17
50840200313648E.M. ADAMS CO, INC26-0654-12022-07-17
50840200314744E.M. ADAMS CO, INCEP28-30205B-12022-07-17
50840200314768E.M. ADAMS CO, INCEP28-30205G-12022-07-17
50840200314782E.M. ADAMS CO, INCEP28-30205U-12022-07-17
50840200314805E.M. ADAMS CO, INCEP28-30206B-12022-07-17
50840200314843E.M. ADAMS CO, INCEP28-30206U-12022-07-17
50840200314867E.M. ADAMS CO, INCEP28-30207B-12022-07-17
50840200314881E.M. ADAMS CO, INCEP28-30207G-12022-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015560728Le SquishFiomet Ventures Inc.FMP2026-05-24
00860015560735Le SquishFiomet Ventures Inc.FMP2026-05-24
00860015560759Le SquishFiomet Ventures Inc.FMP2026-05-24
00860015560766Le SquishFiomet Ventures Inc.FMP2026-05-24
00860015560704Le SquishFiomet Ventures Inc.FMP2026-05-23
00860015560711Le SquishFiomet Ventures Inc.FMP2026-05-23
00860015560742Le SquishFiomet Ventures Inc.FMP2026-05-23
10848530108172CPAP AccessorySUNSET HEALTHCARE SOLUTIONS, INC.FMP2026-02-02
00089904011374Action®ACTION PRODUCTS, INC.FMP2026-01-08
00089904011381Action®ACTION PRODUCTS, INC.FMP2026-01-08
00089904011398Action®ACTION PRODUCTS, INC.FMP2026-01-08
20609271989607Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989614Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989621Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989638Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
00609271989641Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989652Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989669Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989676Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989683Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989690Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989706Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989713Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989720Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989737Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989744Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989751Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989768Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
50749756401437DeRoyalDEROYAL INDUSTRIES, INC.FMP2026-01-01
50749756401444DeRoyalDEROYAL INDUSTRIES, INC.FMP2026-01-01