Question 1

What types of devices does JK-Products GmbH manufacture?

Accepted Answer

JK-Products GmbH manufactures ultraviolet tanning devices, vibration platform exercisers, and hydrotherapy baths/tanks. Their product range includes models like Ergoline ESSENCE 48 SMART POWER, Ergoline Spirit PLT, and Inspiration 550, among others.

The company's portfolio includes Class I and Class II devices, which are listed in the FDA UDI registry. JK-Products GmbH is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is JK-Products GmbH based?

Accepted Answer

JK-Products GmbH is based in the United States, as explicitly stated in the SUMMARY section of the device data. The COUNTRY field also confirms this with the value 'US'. This location refers to the company's headquarters or primary operational base, though no further details about facilities or address are provided in the data.

Question 3

In which regulatory registry are JK-Products GmbH's devices listed?

Accepted Answer

JK-Products GmbH's devices are listed in the FDA UDI registry, as indicated by the 'LISTED IN' field in the device data. This registry is used for tracking medical devices through unique device identifiers in the United States market. The listing does not imply approval or clearance of the devices themselves, only that they are included in this regulatory database.

Question 4

How are JK-Products GmbH's devices classified?

Accepted Answer

JK-Products GmbH's devices are classified as Class I and Class II, according to the DEVICE CLASSES field in the provided data. This classification reflects the risk level associated with the devices, with Class I being low risk and Class II being moderate risk, subject to special controls. The classification applies to individual devices, not the company as a whole, and varies by product type such as ultraviolet tanning devices or vibration platforms.

Device	Model / Reference	Registries	Class	Status
Ergoline/ ESSENCE 48 SMART POWER (PBT)	JK 116 / 48-0	FDA UDI	Class II	Active
Ergoline Spirit PLT	JK 191 / 42-3 PLT	FDA UDI	Class II	Active
Ergoline/Prestige 1400 Intelligent Performance, Soltron XXL-125 EAGLE	JK 127 / 52-4 TT	FDA UDI	Class II	Active
Inspiration 550	JK 126 / 42-4	FDA UDI	Class II	Active
Ergoline Sunrise 6200 Basic Design / Sound / Vibra Shape	JK 158 / 48-0 VS	FDA UDI	Class II	Active
Ergoline/ Open Sun 1050, Soltron XXL-95 SHARK	JK 70 / 0-30	FDA UDI	Class II	Active
Ergoline/PASSION PLUS 40/3 Turbo Power (Black) - PF	JK 103 / 40-3 AC	FDA UDI	Class II	Active
Ergoline/ ESSENCE 48 SMART POWER	JK 116 / 48-0	FDA UDI	Class II	Active
Ergoline/PASSION 34/3 Super Power, Soltron XS-40 KISS	JK 103 / 34-3	FDA UDI	Class II	Active
Ergoline/SUNRISE 480 Turbo Power, Soltron V-55 UNIVERSE	JK 98 / 48-0	FDA UDI	Class II	Active
SUN ANGEL DUO 600 (15min)	JK 126 / SA 42-4 AC	FDA UDI	Class II	Active
Ergoline Sunrise 6200 Basic Design / Sound	JK 158 / 48-0	FDA UDI	Class II	Active
Ergoline Pulse PLT	JK 191 / 40-3 PLT	FDA UDI	Class II	Active
Ergoline/Inspiration 600 Dynamic Performance, Soltron M-60 JUMP	JK 126 / 42-4 AC	FDA UDI	Class II	Active
SUNDASH 32/1 Super Power (20min), Soltron XXS-35 SURF	JK 103 / 32-1	FDA UDI	Class II	Active
Ergoline/SUNRISE 480 Turbo Power (Sound & Ambient Light), Soltron V-55 UNIVERSE	JK 98 / 48-0	FDA UDI	Class II	Active
Ergoline/ SUNRISE 480 Turbo Power + Vibra Shape -PF	JK 98 / 48-0	FDA UDI	Class I	Active
Ergoline Sunrise 6200 Planet Fitness / Sound / Vibra Shape	JK 158 / 48-0 VS	FDA UDI	Class II	Active
Sunangel 400	JK 103 / SA 40-3 AC	FDA UDI	Class II	Active
Ergoline Vitality Hybrid Light 3	JK 164 / 50-4 HLT-3 TT	FDA UDI	Class II	Active
Ergoline/SUNRISE 480 Turbo Power (Sound & Ambient Light), Soltron V-55 UNIVERSE	JK 98 / 48-0	FDA UDI	Class II	Active
Ergoline Prestige 1600 Hybrid Performance	JK 162 / 52-4 TT	FDA UDI	Class II	Active
Ergoline/Inspiration 500 Smart Performance, Soltron M-55 RACER	JK 126 / 38-3 AC	FDA UDI	Class II	Active
Ergoline Spirit HLT	JK 191 / 42-3 HLT	FDA UDI	Class II	Active
Ergoline Sunrise 7200 Hybrid Light Technology Planet Fitness/Sound/Bluetooth/VS	JK 158 / 48-0 HT VS	FDA UDI	Class II	Active
Ergoline SUNRISE 6200 Planet Fitness / Sound	JK 158 / 48 -0	FDA UDI	Class II	Active
Planet Fitness 48/4	JK 79 / 48-4 TT	FDA UDI	Class II	Active
SUNDASH 32/1 Super Power (15min) -PF	JK 103 / 32-1	FDA UDI	Class II	Active
Ergoline Inspiration 550 Hybrid Performance	JK 126 / 42-4 HT	FDA UDI	Class II	Active
Ergoline Sunrise 7200 Hybrid Performance	JK 158 / 48-0 HT	FDA UDI	Class II	Active
Ergoline Sunrise 7200 Hybrid Light Technology Planet Fitness/Sound/Bluetooth	JK 158 / 48-0 HT	FDA UDI	Class II	Active
Ergoline/ SUNRISE 480 Turbo Power	JK 98 / 48-0	FDA UDI	Class II	Active
Revive	JK 194/RV32-0 VBR	FDA UDI	Class I	Active
Ergoline/ SUNRISE 480 Turbo Power	JK 98 / 48-0	FDA UDI	Class II	Active
Beauty Angel 7200	JK 158 / BA VBR	FDA UDI	Class I	Active
Ergoline Affinity 500 Turbo Power	JK 92 / 43-3	FDA UDI	Class II	Active
Ergoline Passion 40/3 Turbo Power, Soltron S-45 Flirt	JK 103 / 40-3	FDA UDI	Class II	Active
Beauty Angel RVT30	JK 98 / BA VBR	FDA UDI	Class I	Active
Ergoline/ SUNRISE 480 Turbo Power + Vibra Shape -PF	JK 98 / 48-0	FDA UDI	Class I	Active
Wellsystem	Wave Touch	FDA UDI	Class I	Active
Ergoline/PASSION PLUS 40/3 Smart Performance	JK 103 / 40-3	FDA UDI	Class II	Active
Revive RVT30	JK 98 / RV 30-0 VBR E	FDA UDI	Class I	Active
SUN ANGEL DUO 1400 (12min)	JK 127 / SA 52-4 TT	FDA UDI	Class II	Active
Ergoline/SUNRISE 480 Turbo Power (Sound & Ambient Light) - PF	JK 98 / 48-0	FDA UDI	Class II	Active
Ergoline/PASSION PLUS 40/3 Turbo Power (Black), Soltron S-45 FLIRT+AC	JK 103 / 40-3 AC	FDA UDI	Class II	Active
Ergoline/ SUNRISE 480 Turbo Power - PF	JK 98 / 48-0	FDA UDI	Class II	Active
Ergoline Vitality Total Light 3	JK 164 / 50-4 TLT-3 TT	FDA UDI	Class II	Active
Ergoline/SUNRISE 480 Turbo Power (Sound & Ambient Light) - PF	JK 98 / 48-0	FDA UDI	Class II	Active
Ergolline Shine PLT	JK 191 / 32-0 PLT	FDA UDI	Class II	Active
Ergoline/SUNRISE 480 Turbo Power, Soltron V-55 UNIVERSE	JK 98 / 48-0	FDA UDI	Class II	Active

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