FDA.reportPublic FDA data

Wellsystem

Primary DI
EJKP100004182A0
Brand
Wellsystem
Company
JK-Products GmbH
Model
Hydrowave Pure
Published
2025-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EJKP100004182A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hydrotherapy bath/tankA bathtub or tank designed to be filled with warm water and occupied by a patient for the application of various forms of physical hydrotherapy such as water jet massage or aquatic exercise, typically to help treat musculoskeletal pain and stiffness or for physical rehabilitation; it is not dedicated to flotation therapy. It may have built-in water jet nozzles or an external heating/pump system to heat and circulate the water (whirlpool effect). This device is intended to be used in a healthcare facility.

Regulatory Flags#

DUNS number
316232073
Device count
1
Premarket exempt
true
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
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
EJKP100003439A0Ergoline SUNRISE 6200 Basic DesignJK 158 / 48-02018-03-13

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Primary DI, Brand, Company table
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