FDA.reportPublic FDA data

E.M Adams co, inc.

Primary DI
10840200304808
Brand
E.M Adams co, inc.
Company
E.M. ADAMS, INC.
Model
3073-1
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
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
50840200304790PackageGS148In Commercial Distribution
10840200304808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5084020030479050840200304790
1084020030480810840200304808

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
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
Premarket exempt
true
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840200302309E.M Adams co, inc.14-3444-12021-05-21
18100013402309E.M Adams co, inc.14-3444-12019-12-31
10840200325599E.M. Adams Co Inc14-70809JK-12023-11-21
50840200325580E.M. Adams Co Inc14-70809JK-12023-11-21
10840200325575E.M. Adams Co, Inc114-A3609-12023-11-17
50840200325566E.M. Adams Co, Inc114-A3609-12023-11-17
10840200301081E.M. Adams Co Inc114-A11341-12023-10-31
50840200301072E.M. Adams Co Inc114-A11341-12023-10-31
10840200325551E.M. Adams Co Inc114-31613-12023-10-31
10840200325537E.M. Adams Co, Inc.14-3497-12023-10-20
50840200325528E.M. Adams Co, Inc.14-3497-12023-10-20
10840200325452E.M. Adams co, inc.EP30405L-12023-06-20
50840200325443E.M. Adams co, inc.EP30405L-12023-06-20
10840200302040E.M Adams co, inc.14-3358-12021-05-21
10840200302217E.M Adams co, inc.14-3392-12021-05-21
10840200302248E.M Adams co, inc.14-3393-12021-05-21
18100013401999E.M Adams co, inc.14-3350-12019-12-31
18100013402040E.M Adams co, inc.14-3358-12019-12-31
18100013402217E.M Adams co, inc.14-3392-12019-12-31
18100013402248E.M Adams co, inc.14-3393-12019-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00089904011404Action®ACTION PRODUCTS, INC.FMP2026-06-08
00505627930841Repose Flex Large x10 &Pump x1Frontier Therapeutics IncFMP2026-06-05
05056279308434Repose Flex Large x1 & Pump x1Frontier Therapeutics IncFMP2026-06-05
05056279308458Repose Flex Large x10 &Pump x10Frontier Therapeutics IncFMP2026-06-05
00860010482674AcanthusAcanthus Medical Creations LLCFMP2026-05-27
10603354600666TruVueEHOB INCFMP2025-03-20
10603354300696WAFFLEEHOB INCFMP2024-12-18
07613327632873Sage TAP LCSAGE PRODUCTS, LLCFMP2024-03-26
G096R9292209LineRising Eagle Medical LLCFMP2024-01-30
20845854082536Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082901Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082918Paradigm RevolutionConmed CorporationFMP2023-06-13
00609271009004DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009011DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009103DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009110DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271166004DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166011DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166028DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166035DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166042DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166059DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166066DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166073DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166080DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166097DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166103DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166110DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166127DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166134DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08