FDA.report

Liko MasterVest™, front closure, Mod. 64

Primary DI
00887761983809
Brand
Liko MasterVest™, front closure, Mod. 64
Company
Liko AB
Model
3564114
Device description
Gait rehabilitation system harness
Published
2021-03-19
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

Related Records

Contact Domains

Product Codes

CodeName
FSALift, patient, non-ac-powered

Product Code Classifications

CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887761983809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761983809008877619838098877619838090887761983809

GMDN Terms

TermDefinition
Gait rehabilitation system harnessA lifting device, in the form of belts and straps, which is a component of a gait rehabilitation system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function. The device is designed to be secured around the patient?s upper body and hips and is intended to help suspend the patient vertically over the floor or a treadmill while attached to the supporting frame of a suspension device; it may be used in conjunction with a robotic orthosis device for the training of normal gait.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)445-3730us.customerservice@hillrom.com

Regulatory Flags

DUNS number
354818510
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

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00887761979529Likorall™ overhead lift31230012021-09-18
00887761979543Likorall™ overhead lift31230022021-09-18
00887761979567Likorall™ overhead lift31240502021-09-18
00887761979758Likorall™ overhead lift31220072021-09-18
00887761979796Likorall™ overhead lift31220092021-09-18
00887761979819Likorall™ overhead lift31220102021-09-18
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