FDA.reportPublic FDA data

FOOTHOLD

Primary DI
30603354400604
Brand
FOOTHOLD
Company
EHOB INC
Model
REV00
Catalog number
FH10LGEX01G
Device description
FOOTHOLD - LARGE W/SPLINT & GAIT ROCKER - SNGL
Published
2020-08-21
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
true

Product Codes#

Code, Name table
CodeName
IQIOrthosis, Limb Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30603354400604PackageGS14In Commercial Distribution
10603354400075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3060335440060430603354400604
1060335440007510603354400075

GMDN Terms#

Term, Definition table
TermDefinition
Ankle/foot orthosisAn externally-applied appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot; it may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds. It is made of metal, synthetic, and/or textile materials and may include customizable plantar inserts. This is a single-patient use device that can be reapplied to the patient during the treatment period (reusable) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
150600252
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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30603354600677TruVueREV00TRU0170A12025-03-20
10603354600680TruVueREV00TRU0170B12025-03-20
10603354600703TruVueREV00TRU0170HAA12025-03-20
30603354120670ComfortTopREV00PPCMFTOP2025-01-22
30603354201652WAFFLEREV002180WCHA0102024-12-18
30603354201676WAFFLEREV002200WCHA0102024-12-18
30603354201690WAFFLEREV002300WCHA0102024-12-18
10603354201702WAFFLEREV002400WCHA0102024-12-18
30603354201737WAFFLEREV002000WCHA0102024-12-18
30603354300706WAFFLEREV005450CXHA0102024-12-18
30603354130198BAMREV00B0155A12024-09-12
10603354130224BAMREV00B0155B12024-09-12
30603354130235BAMREV00B0155C12024-09-12
30603354130259BAMREV00B0165A12024-09-12
30603354130273BAMREV00B0165B12024-09-12
30603354130297BAMREV00B0165C12024-09-12
30603354130310BAMREV00B0166A12024-09-03
30603354130334BAMREV00B0166B12024-09-03
30603354130358BAMREV00B0166C12024-09-03
10603354130439BAMREV00Z0156A12024-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840194499194Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499200Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499217Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499224Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499231Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499248Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499255Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499262Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00840194499279Contracture ManagementORTHOPEDIATRICS CORP.IQI2026-03-02
00645517899350TrulifeTRULIFE LIMITEDIQI2026-02-17
00645517899367TrulifeTRULIFE LIMITEDIQI2026-02-17
00645517899374TrulifeTRULIFE LIMITEDIQI2026-02-17
00645517899381TrulifeTRULIFE LIMITEDIQI2026-02-17
00860014768606QuickBraceINNOMOTIVE L.L.CIQI2026-02-11
00690079011306Strassburg SockSTRASSBURG MEDICAL, LLCIQI2026-01-27
00690079011313Strassburg SockSTRASSBURG MEDICAL, LLCIQI2026-01-27
00690079012303Strassburg SockSTRASSBURG MEDICAL, LLCIQI2026-01-27
00690079012310Strassburg SockSTRASSBURG MEDICAL, LLCIQI2026-01-27
00810113682969ManaEZ Single Panel Knee Immobilizer 18"Manamed, Inc.IQI2025-11-25
00810113682976ManaEZ Single Panel Knee Immobilizer 20"Manamed, Inc.IQI2025-11-25
00810113682983ManaEZ Single Panel Knee Immobilizer 24"Manamed, Inc.IQI2025-11-25
00810113682990ManaEZ 3 Panel Knee Immobilizer 18"Manamed, Inc.IQI2025-11-25
00810113683003ManaEZ 3 Panel Knee Immobilizer 20"Manamed, Inc.IQI2025-11-25
00810113683010ManaEZ 3 Panel Knee Immobilizer 24"Manamed, Inc.IQI2025-11-25
00810113683294ManaEZ 3 Panel Knee Immobilizer 16"Manamed, Inc.IQI2025-11-25
00810079192144Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-24
00810079192151Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-24
00810079191918Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-17
00810079191925Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-17
00810079192311Thrive OrthopedicsThrive Orthopedics LLCIQI2025-11-17