FDA.reportPublic FDA data

ESPIRE

Primary DI
05056394328485
Brand
ESPIRE
Company
HUGH STEEPER LIMITED
Model
Espire Elbow Pro- Right- Silver- Small- COAPT
Catalog number
EEP-RSS-CO
Published
2023-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IREJoint, Elbow, External Limb Component, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IREJoint, Elbow, External Limb Component, PoweredPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182757000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182757000Espire Elbow Pro, Espire Elbow HybridCollege Park Industries, Inc.2018-11-29GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056394328485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056394328485050563943284855056394328485

GMDN Terms#

Term, Definition table
TermDefinition
Electrical elbow prosthesisAn 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. The control of the device is achieved by an electromechanical switch for the motor that is operated by body movement using straps or cables.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
210280350
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05063368529106BATTERY SYSTEMLITHIUM BATTERY CHARGERLIBCH2023-10-04
05063368529502BATTERY SYSTEM50MM KINISI SH WR HOUSINGMKSW502023-10-04
05063368529496BATTERY SYSTEM45MM KINISI SH WR HOUSINGMKSW452023-10-04
05063368529519BATTERY SYSTEM50MM KINISI SH WR HOUSING M12BBSW50-M122023-10-04
05055348200228S-CHARGES-Charger - Wall Charger KitSWC22002023-08-08
05055348200068MYO"Myoelectric Hand Quick Disconnect Wrist 6 3/4"" LMYA675LQD2023-08-04
05055348200075MYO"Myoelectric Hand Quick Disconnect Wrist 6 3/4"" RMYA675RQD2023-08-04
05055348248305MYOMyoelectric Hand Quick Disconnect Wrist 7 3/4 RighMYA775RQD2023-08-04
05055348248312MYOMyoelectric Hand Quick Disconnect Wrist 8 1/4 RighMYA825RQD2023-08-04
05056349591032MYOMYO Configuration DeviceMYO-CFG2023-08-04
05056701110802S-CHARGE3500 mAh BATTERYSC3500B2023-08-07
05055348202932MYO50MM SH WR HOUSINGBBSW502023-08-02
05055348244116MYOON/OFF SWITCH AND CHARGE PORTB278042023-08-02
05063368216198MYOSDU CONE ASSEMBLYB307002023-08-02
05055348200181ElectrodeELECTRODE CABLEECA-3002023-07-10
05055348200198ElectrodeELECTRODE CABLEECA-6002023-07-10
05055348200204ElectrodeELECTRODE CABLEECA-10002023-07-10
05055348203304Electrode50Hz ELECTRODEELEC502023-07-10
05055348203311Electrode60Hz ELECTRODEELEC602023-07-10
05055348203328ELECTRODE50Hz ELECTRODE SEAL IN KITELSK502023-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00855846007245MyoPro 2x Assembly KitMyomo, Inc.IRE2024-12-11
00855846007252MyoPro 2x Assembly KitMyomo, Inc.IRE2024-12-11
00855846007238Mobile Arm Rehabilitation Kit version 2 (MARK2)Myomo, Inc.IRE2024-10-11
00855846007214MyoPro 2xMyomo, Inc.IRE2024-09-20
00855846007221MyoPro 2xMyomo, Inc.IRE2024-09-20
05056394328072ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328089ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328133ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328140ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328157ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328171ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328188ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328195ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328263ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328294ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328300ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328317ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328324ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328331ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328379ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328393ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328416ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328423ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328430ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394328447ESPIREHUGH STEEPER LIMITEDIRE2023-06-30
05056394327266ESPIREHUGH STEEPER LIMITEDIRE2023-06-29
05056394327280ESPIREHUGH STEEPER LIMITEDIRE2023-06-29
05056394327341ESPIREHUGH STEEPER LIMITEDIRE2023-06-29
05056394327372ESPIREHUGH STEEPER LIMITEDIRE2023-06-29
05056394327556ESPIREHUGH STEEPER LIMITEDIRE2023-06-29