Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615023

FEI Number

3004373978

Entity Name

JK PRODUCTS GMBH

City/State/Country

BAD HONNEF North Rhine-Westphalia, DE

Establishment Address

ROTTBITZER STRASSE 69, BAD HONNEF North Rhine-Westphalia 53604, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

JK PRODUCTS GMBH (Owner Number: 9034303)

Owner / Operator Contact Address

ROTTBITZER STRASSE 69, --, BAD HONNEF, DE-NOTA 53604, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190173

PMA Number

N/A

All Registered Proprietary Names

Ergoline Prestige 1600 Hybrid Performance Ergoline Sunrise 7200 Hybrid Technology/Sound/Bluetooth/Vibra Shape Ergoline Sunrise 7200 Hybrid Light Technology Planet Fitness/Sound/Bluetooth Ergoline Sunrise 7200 Hybrid Light Technology Planet Fitness/Sound/Bluetooth/Vibra Shape Ergoline Sunrise 7200 Hybrid Technology/Sound Bluetooth ESSENCE VIBRA SHAPE Beauty Angel SUNRISE VIBRA SHAPE Beauty Angel 7200 Ergoline/ Flair 32/1 Super Power (20 min) Ergoline/Prestige 1400 Intelligent Performance / Soltron XXL-125 EAGLE Ergoline / Passion 34 Super Power(20 min) Ergoline/Sun Select 1400 Intelligent Performance Sun Angel Duo S 52(15 min) Ergoline/ ESSENCE 48 SMART POWER (PBT) SUN ANGEL DUO 1400 (12 min) SUN ANGEL DUO 1400 (15 min) Ergoline/AFFINITY 500 Turbo Power Sun Angel S 52 (15 min) Sun Angel S 52(20 min) Ergoline/ ESSENCE 48 SMART POWER (Grey) / Soltron V-50 SPACE CAB Sun Angel Duo S 52(20 min) Ergoline/AFFINITY 800 Turbo Power Temptronic Ergoline/AFFINITY 900 Advanced Performance / Soltron XL-85 WILDCAT Ergoline/ Open Sun 1050/ Soltron XXL-95 SHARK Soltron/ XXL-110 DYNAMIC POWER (Blueberry Blue) Ergoline/PASSION PLUS 40/3 Smart Performance Ergoline/Inspiration 600 Dynamic Performance / Soltron M-60 JUMP Ergoline/PASSION PLUS 40/3 Turbo Power (WHITE)/ Soltron S-45 FLIRT+AC Ergoline/Inspiration 500 Smart Performance / Soltron M-55 RACER SUN ANGEL DUO 600(20 min) Ergoline/AFFINITY 700 Advanced Performance AC / Soltron L-70 BUTTERFLY Ergoline/SUNRISE 480 Turbo Power/ Soltron V-55 UNIVERSE Palm Beach Tan / SIGNATURE Ergoline/ Flair 32/3 Super Power (15 min) SUNDASH 32/1 Super Power (20 min) / Soltron XXS-35 SURF Ergoline/ ESSENCE 48 SMART POWER (Red) Ergoline/PASSION 34/3 Super Power/ Soltron XS-40 KISS SUNANGEL 400 Ergoline/AFFINITY 700 Advanced Performance / Soltron L-70 BUTTERFLY Ergoline/ Flair 32/1 Super Power (15 min) Ergoline/ Flair 32 Super Power (15 min) Ergoline/ Flair 32 Super Power (20 min) Ergoline/PASSION PLUS 40/3 Turbo Power (BLACK)/ Soltron S-45 FLIRT+AC Soltron/ XL-80 DYNAMIC POWER (Magic Melon) Ergoline Inspiration 550 SUNDASH 32 Super Power / Soltron XXS-35 SURF Ergoline/PASSION 40/3 Turbo Power (WHITE)/ Soltron S-45 FLIRT SUN ANGEL DUO 600 (15 min) Ergoline/ Flair 32/3 Super Power (20 min) Ergoline/SUNRISE 480 Turbo Power (Sound & Ambient Light)/ Soltron V-55 UNIVERSE Ergoline/Sun Select 1000 Intelligent Performance Sun Angel S 46 Planet Fitness 48/4 SUNDASH 32/1 Super Power (15 min) / Soltron XXS-35 SURF Soltron/ Coco Cabana XXS-35 Ergoline/PASSION 40/3 Turbo Power (BLACK)/ Soltron S-45 FLIRT Ergoline/AFFINITY 600 Turbo Power Air Condition Soltron/XXS-30 Super Power (Mango Tango) Ergoline / Passion 34 Super Power(15 min) Ergoline/Prestige 1000 Intelligent Performance / Soltron XXL-115 STARLIGHT Planet Fitness 42/4 Ergoline Shine PLT Ergoline Sunrise 6200 Planet Fitness Ergoline Sunrise 6200 Basic Design / Sound / Bluetooth / Vibra Shape Ergoline Sunrise 6200 Planet Fitness / Sound / Bluetooth / Vibra Shape Ergoline Sunrise 7200 Advanced Design / Sound / Bluetooth / Vibra Shape Ergoline Sunrise 6200 Basic Design Ergoline Sunrise 7200 Advanced Design Wellsystem Medical Plus Wellsystem Medical Ergoline Inspiration 550 Hybrid Technology / AC / Sound Ergoline Inspiration 550 Hybrid Technology / Sound Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LEJ	Booth, Sun Tan	General, Plastic Surgery	Class 2	878.4635	2018-10-29
LEJ	Booth, Sun Tan	General, Plastic Surgery	Class 2	878.4635	2019-04-12
BXB	Exerciser, Powered	Physical Medicine	Class 1	890.5380	2015-07-02
LEJ	Booth, Sun Tan	General, Plastic Surgery	Class 2	878.4635	2015-12-03
LEJ	Booth, Sun Tan	General, Plastic Surgery	Class 2	878.4635	2018-12-20
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2004-04-15
LEJ	Booth, Sun Tan	General, Plastic Surgery	Class 2	878.4635	2019-05-13

Official Correspondent

No official correspondent registered.

US Agent Details

Marie Merill Business: Executive Director Operations Email: mariem@jkamerica.com Phone: (870) 3361570

Related Public Records

Same Entity

JK PRODUCTS GMBH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K875190	Ultra Tan Intl. AB	ULTRA TAN PURPLE PRO	1988-01-14

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615023. Last updated year: 2026. Please use registration number 9615023 when referencing this establishment in official correspondence.