Data / Medical devices / Germany / JK Products GMBH
JK Products GMBH: FDA-registered device maker in BAD HONNEF North Rhine-Westphalia, Germany, 6 510(k) clearances
JK Products GMBH is registered with the FDA (registration 9615023) in BAD HONNEF North Rhine-Westphalia, Germany. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 1, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615023
- FEI number
- 3004373978
- Address
- Rottbitzer Strasse 69, BAD HONNEF North Rhine-Westphalia, Germany, 53604
- Owner or operator
- JK PRODUCTS GMBH (9034303)
- Roles
- Manufacturer
- First device listed
- April 15, 2004
- Registered through
- 2026
- Brand names listed
- Beauty Angel, Beauty Angel 7200, ESSENCE VIBRA SHAPE, Elements Synergy, Ergoline / Passion 34 Super Power(15 min), Ergoline / Passion 34 Super Power(20 min), Ergoline Inspiration 550, Ergoline Inspiration 550 Hybrid Technology / AC / Sound and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Booth, Sun Tan | LEJ | 2 | Manufacturer | accessdata.fda.gov |
| Exerciser, Powered | BXB | 1 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 1, 2022 | K220500 | Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline | LEJ | Substantially Equivalent | Jk-Holding GmbH | accessdata.fda.gov |
| May 10, 2019 | K190173 | Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound | LEJ | Substantially Equivalent | Jk-Holding GmbH | accessdata.fda.gov |
| April 8, 2019 | K183539 | Ergoline Sunrise 7200 Hybrid Technology | LEJ | Substantially Equivalent | Jk-Holding GmbH | accessdata.fda.gov |
| October 11, 2018 | K180555 | Ergoline Prestige 1600 Hybrid Performance | LEJ | Substantially Equivalent | Jk Holding GmbH | accessdata.fda.gov |
| February 14, 2018 | K173565 | Sunrise 6200, Sunrise 7200 | LEJ | Substantially Equivalent | Jk-Holding GmbH | accessdata.fda.gov |
| September 16, 2015 | K151400 | Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products | LEJ | Substantially Equivalent | Jk Holding GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Booth, Sun Tan
- All makers of Massager, Therapeutic, Electric
- All makers of Exerciser, Powered
Updated July 1, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.