FDA.reportPublic FDA data

EQUATE

Primary DI
30194346098058
Brand
EQUATE
Company
COMPASS HEALTH BRANDS CORP.
Model
FGP507EQ WMRT
Device description
EQ ADAPTIVE CUTLERY
Published
2023-08-04
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
ILCUtensil, Eating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILCUtensil, EatingPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30194346098058PackageGS14In Commercial Distribution
00194346098057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3019434609805830194346098058
00194346098057001943460980571943460980570194346098057

GMDN Terms#

Term, Definition table
TermDefinition
Assistive cutleryA device designed as an eating utensil (e.g., a specialized knife, spoon, or fork) used by a person with a disability to cut food and/or to transfer food into their mouth. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-376-7263CustomerService@compasshealthbrands.com

Regulatory Flags#

DUNS number
827221698
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30194346615156Equate 72085EQ2026-01-20
40076855700608Apex70060BPKG2025-08-28
30023601200519AccuReliefACRL-00512025-07-17
30092237628561TENS 7000DT7308-ELEC42025-07-10
30092237628554TENS 7000DT7307-ELEC82025-06-30
30023601088209CarexFGE82000 00002025-06-25
30627394040019Pain CakesTMF70001CA2025-06-03
30627394040057Pain CakesTMF70005CA2025-06-03
30627394040064Pain CakesTMF70006CA2025-06-03
30023601017100CAREX HEALTH BRANDSFGA71000 00002025-05-21
30627394023036CarexFGB303CA2025-05-13
50023601023037CarexFGB30300 00002025-02-19
80092237626845TENS 7000DT73152025-01-21
30092237626734TENS 7000DT73092025-01-06
30092237626741TENS 7000DT73102025-01-06
30092237626758TENS 7000DT73142025-01-06
30632615880107Bed BuddyBBF8010-122024-12-18
30023601261008AccuReliefACRL-52002024-12-17
30041520865817Apex70010AHO2024-12-09
30635515992765Apex70010QC2024-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226440104ViveVIVE HEALTH LLCILC2026-06-04
00810226440111ViveVIVE HEALTH LLCILC2026-06-04
00661392008076LSL HEALTHCARELSL Industries, LLCILC2025-05-15
10661392008073LSL HEALTHCARELSL Industries, LLCILC2025-05-15
00057475541019BIOS LivingThermor LtdILC2024-03-21
10057475541016BIOS LivingThermor LtdILC2024-03-21
00023601035073CarexDrive Devilbiss HealthcareILC2023-12-07
30023601035074CarexCOMPASS HEALTH BRANDS CORP.ILC2023-12-07
00194346098057EQUATEDrive Devilbiss HealthcareILC2023-08-04
00859911004825SafeStrawBionix, LLCILC2023-07-19
00859911004832SafeStrawBionix, LLCILC2023-07-19
10859911004822SafeStrawBionix, LLCILC2023-07-19
10859911004839SafeStrawBionix, LLCILC2023-07-19
10686864048777SOLONAMD Medicom IncILC2023-07-10
10686864048821AMD-RITMED SOLONAMD Medicom IncILC2023-07-10
20686864048774SOLONAMD Medicom IncILC2023-07-10
20686864048828AMD-RITMED SOLONAMD Medicom IncILC2023-07-10
07320450002021Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002038Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002045Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002052Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002076Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002083Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002090Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002106Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002113Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002120Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002168Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002175Etac Supply Center ABEtac Supply Center ABILC2022-12-07
07320450002182Etac Supply Center ABEtac Supply Center ABILC2022-12-07