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Tactile Medical

FDA Regulatory Profile

Tactile Medical has 0 FDA recalls, 0 inspections, 3 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Tactile Medical".

Latest 510(k)
Jul 31, 2026

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances3Nov 8, 2026File dated Nov 2, 2026Current
Inspections0Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent 510(k) clearances

3 510(k) clearances from Jun 21, 2024 to Jul 31, 2026.

K-NumberDeviceDate
K253555Flexitouch® Plus Advanced Pneumatic Compression SystemJul 31, 2026
K252849AffloVest® Mobile Airway Clearance TherapyApr 30, 2026
K234155Nimbl (model PD08-N1)Jun 21, 2024

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FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.