FDA.report

Stand Assist Electric Lifter

Primary DI
00616784070216
Brand
Stand Assist Electric Lifter
Company
DYNAREX CORPORATION
Model
10702
Published
2019-09-25
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

Product Codes

CodeName
FNGLift, Patient, Ac-Powered
FSALift, Patient, Non-Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
FNGLift, Patient, Ac-PoweredGeneral Hospital2
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784070216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784070216006167840702166167840702160616784070216

GMDN Terms

TermDefinition
Standing transfer platform, electricA battery-powered device designed as a platform for use by healthcare professionals to assist in the physical moving (transfer) of a person with a disability in an upright (standing) position over a short distance on a horizontal plane, e.g., from one place to another within an institution or building. The device consists of an electrically-powered wheeled platform with a low centre of gravity and a surrounding framework with body securing devices (e.g., belts, foot straps, knee pads) to hold the person being transfered in the standing position. It may include powered mechanisms to raise or lower the platform and to make it move. It is not intended to facilitate gait.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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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