FDA.reportPublic FDA data

Ergoline/ SUNRISE 480 Turbo Power + Vibra Shape -PF

Primary DI
EJKP100003355A0
Brand
Ergoline/ SUNRISE 480 Turbo Power + Vibra Shape -PF
Company
JK-Products GmbH
Model
JK 98 / 48-0
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
BXBExerciser, Powered
LEJBooth, Sun Tan

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1
LEJBooth, Sun TanGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EJKP100003355A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vibration platform exerciser, stationaryA non-mobile, mains electricity (AC-powered) device designed to generate vertical high-intensity vibrations intended to traverse the body [whole body vibration (WBV)] and cause involuntary muscle contractions to help strengthen/tone muscles and tendons, increase blood flow and joint range of motion, and provide body massage and other health benefits. It consists of a motorized platform/plate, typically with a pole with a digital display/handrails, upon which the user can stand, sit, lay, or apply a specific body part. It may include accessories for specific training (e.g., resistance) and may be used in the home and athletic/clinical settings for rehabilitation or weight loss applications.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316232073
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EJKP100004142A0Ergoline Prestige Fusion EdgeMODEL-NO: JK 205 / 52-4 HLT AC2026-01-05
EJKP100004143A0Ergoline Prestige Synergy EDGEMODEL-NO: JK 205 / 52-4 HLT AC2026-01-05
EJKP100004088A0Recovery 7200 PFJK 158/RV32-0 VBR2025-12-10
EJKP100004182A0WellsystemHydrowave Pure2025-10-30
EJKP100004192A0Red Wave Recovery JK 194/RV32-10 VBR2025-10-30
EJKP100004099Elements SynergyJK 186 / 44-4 AC2025-10-01
EJKP100003993A0Planet Fitness 40/3 HLT Plus JK 191 / 40-3 HLT2025-04-30
EJKP100003996A0Ergolline Shine PLT JK 191 / 32-0 PLT2025-04-30
EJKP100003999A0Ergoline Pulse PLT JK 191 / 40-3 PLT AC2025-04-30
EJKP100004000A0Ergoline Spirit HLTJK 191 / 42-3 HLT AC2025-04-30
EJKP100004001A0Ergoline Spirit PLTJK 191 / 42-3 PLT AC2025-04-30
EJKP100004083A0Ergoline Spirit HLT JK 191 / 42-3 HLT2025-04-30
EJKP100004084A0Ergoline Spirit PLTJK 191 / 42-3 PLT2025-04-30
EJKP100004085A0Planet Fitness 40/3 HLT Plus JK 191 / 40-3 HLT AC2025-04-30
EJKP100004086A0Planet Fitness 40/1 PLT Plus JK 191 / 40-1 PLT AC2025-04-30
EJKP100004087A0Ergoline Pulse PLT JK 191 / 40-3 PLT2025-04-30
EJKP100004042A0Ergoline Vitality Pure Light 3 (10 min)JK 164 / 50-4 PLT-3 AC2024-02-28
EJKP100003952B0ReviveJK 194/RV32-0 VBR2023-12-01
EJKP100003960B0Revive RVT30JK 98 / RV 30-0 VBR E2023-12-01
EJKP100003973A0Revive PRO IRJK 194/RV32-10 VBR2023-11-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08600124614279Ultrasun Q6-2 Magnum PowerUltrasun International B.V.LEJ2026-07-03
08600124614309Ultrasun Q10-0Ultrasun International B.V.LEJ2026-07-03
08600124614316Ultrasun Q10-3 Magnum PowerUltrasun International B.V.LEJ2026-07-03
08600124614378Ultrasun Q16-3Ultrasun International B.V.LEJ2026-07-03
08600124614392Ultrasun Q18-4x500 MPUltrasun International B.V.LEJ2026-07-03
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G5103178RENUVATANLight Sources, Inc.LEJ2026-04-22