Proactive Comfort, LLC FDA Record
- No warning letters matched by name
Proactive Comfort, LLC has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Proactive Comfort, LLC" is on file.
- Latest 510(k)
- Mar 31, 2016
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 | 1 | 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 |
|---|---|---|
| K152021 | Pure Tilt | Mar 31, 2016 |
Proactive Comfort, LLC and the FDA: common questions
Has Proactive Comfort, LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Proactive Comfort, LLC" 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 Proactive Comfort, LLC received an FDA Form 483?
FDA has not published a Form 483 for "Proactive Comfort, LLC" in its reading room. FDA publishes some Form 483s, not all of them.
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