Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

Jk-Holding GmbH

Windhagen, DE

Jk-Holding GmbH appears in FDA device records in Windhagen, DE. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 6 510(k) clearances for Jk-Holding GmbH between 2015 and 2022. The busiest year on record is 2018, with 2. The most recent is 2022, with 1.

Clearances by year, as a table
510(k) clearance decisions for Jk-Holding GmbH, by decision year
YearClearances
20151
20182
20192
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K220500Ergoline 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 ErgolineLEJSubstantially Equivalent
K190173Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / SoundLEJSubstantially Equivalent
K183539Ergoline Sunrise 7200 Hybrid TechnologyLEJSubstantially Equivalent
K180555Ergoline Prestige 1600 Hybrid PerformanceLEJSubstantially Equivalent
K173565Sunrise 6200, Sunrise 7200LEJSubstantially Equivalent
K151400Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp ProductsLEJSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Jk-Holding GmbH edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Jk-Holding GmbH. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

Data as of , FDA export datePage updated Source: openFDA, public domain