Dane Technologies
FDA Regulatory Profile
Dane Technologies has 0 FDA recalls, 5 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- Aug 25, 2025 · VAI
- Latest 510(k)
- Jan 28, 2008
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 5 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Aug 25, 2025 | Maple Grove, MN | Devices | Voluntary Action Indicated (VAI) | 3003857817 |
| Mar 18, 2022 | Maple Grove, MN | Devices | Voluntary Action Indicated (VAI) | 3003857817 |
| Apr 27, 2018 | Maple Grove, MN | Devices | No Action Indicated (NAI) | 3003857817 |
| Oct 17, 2012 | Maple Grove, MN | Devices | Voluntary Action Indicated (VAI) | 3003857817 |
| Jun 17, 2010 | Maple Grove, MN | Devices | Voluntary Action Indicated (VAI) | 3003857817 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3003857817 | Maple Grove, MN | 5 | Aug 25, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K073701 | DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000 | Jan 28, 2008 |