Soleus Champ International Co., Ltd. FDA Record
Soleus Champ International Co., Ltd. has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Soleus Champ International Co., Ltd." is on file.
- Latest 510(k)
- Mar 14, 2005
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 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 |
|---|---|---|
| K043511 | SOLEUS POWERED WHEELCHAIR, MODEL FAD-2 | Mar 14, 2005 |
Soleus Champ International Co., Ltd. and the FDA: common questions
Has Soleus Champ International Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Soleus Champ International Co., Ltd." 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 Soleus Champ International Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Soleus Champ International Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
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