FDA.report

Protekt Pilot

Primary DI
05060488571787
Brand
Protekt Pilot
Company
PROACTIVE MEDICAL PRODUCTS, LLC
Model
UPWLKALDLX19BL
Catalog number
UPWLKALDLX19BL
Device description
Protekt Pilot Upright Walker Aluminum w/ Stand Assist Handles w/ 19" Seat w/ LED Light - Blue
Published
2021-04-12
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
ITJWalker, Mechanical

Product Code Classifications

CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060488571787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060488571787050604885717875060488571787

GMDN Terms

TermDefinition
Standing transfer platform, manualA manually-operated device designed as a platform for use by healthcare professionals to assist in the physical moving (transfer) of a patient with a disability in an upright (standing) position over a short distance on a horizontal plane. The device consists of a wheeled platform with a low centre of gravity and a surrounding framework, shinpad and/or handlebar; it may include body securing devices (e.g., belts, foot straps, knee pads) to hold the person being transferred in the standing position. It is neither intended to mechanically assist standing nor facilitate gait.

Device Sizes

TypeValueUnit
Height71Inch
Length30Inch
Width19Inch

Sterilization Methods

Method

Contacts

PhoneEmail
+1 855 237 7622sales@proactivemedical.com

Regulatory Flags

DUNS number
078582655
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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05060488573996ProtektPMSEBFRPMSEBFR2022-11-23
05060488574009ProtektPMFEBHRPMFEBHR2022-11-23
05060488574016ProtektPMFEBFRPMFEBFR2022-11-23
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05060488572944Protekt PartsPP-RATK3PP-RATK32022-11-18
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05060488572975Protekt PartsPP-RATNWPP-RATNW2022-11-18
05060488572982Protekt PartsPP-RATSWPP-RATSW2022-11-18
05060488573002Protekt PartsPP-HDSFPP-HDSF2022-11-18
05060488573019Protekt PartsPP-RATWWPP-RATWW2022-11-18
05060488573026Protekt PartsPP-SFPP-SF2022-11-18
05060488573033Protekt PartsPP-ELRPP-ELR2022-11-18
05060488573040Protekt PartsPP-JRSFPP-JRSF2022-11-18
05060488573057Protekt PartsPP-RAPDPP-RAPD2022-11-18
05060488573064Protekt PartsPP-RATBWPP-RATBW2022-11-18
05060488573071Protekt PartsPP-RAPFPP-RAPF2022-11-18

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