Jk-Holding GmbH FDA Record
- No warning letters matched by name
Jk-Holding GmbH has 0 FDA recalls, 0 inspections, 6 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Jk-Holding GmbH" is on file.
- Latest 510(k)
- Jul 1, 2022
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 6 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 0 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K220500 | Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by… | Jul 1, 2022 |
| K190173 | Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC… | May 10, 2019 |
| K183539 | Ergoline Sunrise 7200 Hybrid Technology | Apr 8, 2019 |
| K180555 | Ergoline Prestige 1600 Hybrid Performance | Oct 11, 2018 |
| K173565 | Sunrise 6200, Sunrise 7200 | Feb 14, 2018 |
| K151400 | Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products | Sep 16, 2015 |
Jk-Holding GmbH and the FDA: common questions
Has Jk-Holding GmbH received an FDA warning letter?
No FDA warning letter addressed to the name "Jk-Holding GmbH" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Jk-Holding GmbH received an FDA Form 483?
FDA has not published a Form 483 for "Jk-Holding GmbH" in its reading room. FDA publishes some Form 483s, not all of them.
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