FDA applicant

Tactile Systems Technology, Inc.

Minneapolis, MN5 decisions2002–20150 recalls

FDA records 5 decisions for Tactile Systems Technology, Inc. (Minneapolis, MN) from 2002 to 2015: 5 510(k) clearances. Most are in product codes JOW (Sleeve, Limb, Compressible) and IRP (Massager, Powered Inflatable Tube). Its devices cite 10 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Tactile Systems Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tactile Systems Technology, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tactile Systems Technology, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Tactile”

FDA records each applicant name separately; these may or may not be the same firm.

Tactile Systems Technology, Inc. (Dba Tactile Medical) 3 Tactile Medical 3 Tactile Technologies, Ltd. 2

Tactile Systems Technology, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Tactile”