FDA.reportPublic FDA data

Zephyr Patient Positioning and Transfer System

Primary DI
B237ZXLADK600
Brand
Zephyr Patient Positioning and Transfer System
Company
Diacor, Inc.
Model
ZXL-ADK-60
Device description
Starpax Docking Kit for Zephyr Hoverboards
Published
2023-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHNSystem, Radiation Therapy, Charged-Particle, Medical
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHNSystem, Radiation Therapy, Charged-Particle, MedicalRadiology2
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121929000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121929000ZEPHYR 'X-SERIES PATIENT TRANSFER SLEDDiacor, Inc.2013-01-17FRZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B237ZXLADK600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiological whole-body positionerA device comprised of fixed or adjustable position elements designed to ensure adequate positioning and/or immobilization of a patient's whole body during diagnostic imaging, image guided surgical or interventional procedures, and/or radiation therapy procedures; it may in addition be used to position a patient’s body part (however it is not dedicated to a specific part of the body). It is in the form of a frame, board, cushion, or preformed pad and may be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801-467-0050Sales@DiacorInc.com

Regulatory Flags#

DUNS number
605813559
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B237ZEPACR110Zephyr Patient Positioning and Transfer SystemZEP-ACR-112025-12-23
B237ZCPAST100Zephyr Patient Positioning and Transfer SystemZCP-AST-102025-11-13
B237ZEPAUB800Zephyr Patient Positioning and Transfer SystemZEP-AUB-802025-09-26
B237ZEPATG030Zephyr Patient Positioning and Transfer SystemZEP-ATG-032025-08-13
B237ZEPAFR200Zephyr Patient Positioning and Transfer SystemZEP-AFR-202023-06-12
B237ZBL25000Zephyr Patient Positioning and Transfer SystemZBL-2-5002024-07-11
B237ZEPAPS100Zephyr Patient Positioning and Transfer SystemZEP-APS-102024-07-11
B237ZEPAPS110Zephyr Patient Positioning and Transfer SystemZEP-APS-112024-07-11
B237ZEPAPS120Zephyr Patient Positioning and Transfer SystemZEP-APS-122024-07-11
B237ZEPAPS500Zephyr Patient Positioning and Transfer SystemZEP-APS-502024-07-11
B237ZEPASC010Zephyr Patient Positioning and Transfer SystemZEP-ASC-012024-07-11
B237ZEPASC100Zephyr Patient Positioning and Transfer SystemZEP-ASC-102024-07-11
B237ZEPASC500Zephyr Patient Positioning and Transfer SystemZEP-ASC-502024-07-11
B237ZXLACA100Zephyr Patient Positioning and Transfer SystemZXL-ACA-102024-07-11
B237ZXLACI150Zephyr Patient Positioning and Transfer SystemZXL-ACI-152024-07-11
B237ZXLACI160Zephyr Patient Positioning and Transfer SystemZXL-ACI-162024-07-11
B237ZXLADK040Zephyr Patient Positioning and Transfer SystemZXL-ADK-042024-07-11
B237ZBLABF010Zephyr Patient Positioning and Transfer SystemZBL-ABF-012023-06-12
B237ZBLAWP010Zephyr Patient Positioning and Transfer SystemZBL-AWP-012023-06-12
B237ZBLHIN100Zephyr Patient Positioning and Transfer SystemZBL-HIN-102023-06-12

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