FDA.reportPublic FDA data

Espire Elbow Hybrid

Primary DI
00841747182402
Brand
Espire Elbow Hybrid
Company
COLLEGE PARK INDUSTRIES, INC.
Model
EEH RJLS CO
Device description
Espire Elbow Hybrid, Right, Jet Black, Lateral Dial, Small, COAPT
Published
2020-06-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841747182402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841747182402008417471824028417471824020841747182402

GMDN Terms#

Term, Definition table
TermDefinition
Myoelectric elbow prosthesisA powered artificial substitute for a missing elbow used as part of an upper-limb external prosthetic system and designed to restore some of the function of the joint. The device moves as the result of external motor power applied directly or via a connection with another functional limb component. Surface electrodes embedded in the device make contact with the skin and amplify muscle action potentials from voluntary contracting muscle in the residual limb/trunk, which turns on the motor to provide a function.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-728-7950orders@college-park.com

Regulatory Flags#

DUNS number
623191137
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841747186936Aura PlusAHKA 5002026-01-29
00841747186943Aura PlusAHKA 5502026-01-29
00195411458905IconIC CB G2025-05-28
00841747186912Endoskeletal ComponentsTA WT250 302025-05-28
00841747186929Endoskeletal ComponentsTA WT430 302025-05-28
00841747183973SterlingSLK G3L US12024-11-01
00841747183997SterlingSLK G3C UL22024-11-01
00841747184000SterlingSLK G3C UM+22024-11-01
00841747184017SterlingSLK G3C UM22024-11-01
00841747184024SterlingSLK G3C US22024-11-01
00841747184031SterlingSLK G9L UXL22024-11-01
00841747184048SterlingSLK G9L UL+22024-11-01
00841747184055SterlingSLK G9L UL22024-11-01
00841747184062SterlingSLK G9L UM+22024-11-01
00841747184079SterlingSLK G9L UM22024-11-01
00841747184086SterlingSLK G9L US22024-11-01
00841747184093SterlingSLK G6L UXL22024-11-01
00841747184109SterlingSLK G6L UL+22024-11-01
00841747184116SterlingSLK G6L UL22024-11-01
00841747184123SterlingSLK G6L UM+22024-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372163CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372187CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372200CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372224CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372248CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372262CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372286CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372309CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372323CadwellTechnomed Engineering B.V.GXY2024-05-02