Ergoline/ SUNRISE 480 Turbo Power + Vibra Shape

GUDID EJKP100003334A0

JK-Products GmbH

Vibration platform exerciser, stationary
Primary Device IDEJKP100003334A0
NIH Device Record Key33f551ff-b6b8-4b27-98db-0b91809b6c51
Commercial Distribution StatusIn Commercial Distribution
Brand NameErgoline/ SUNRISE 480 Turbo Power + Vibra Shape
Version Model NumberJK 98 / 48-0
Company DUNS316232073
Company NameJK-Products GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEJKP100003334A0 [Primary]

FDA Product Code

BXBExerciser, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

On-Brand Devices [Ergoline/ SUNRISE 480 Turbo Power + Vibra Shape]

EJKP100003334A0JK 98 / 48-0
EJKP100003333A0JK 98 / 48-0

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