510(k) Report

FDA applicant

Tohkai Precision Ind., Ltd.

Saint Petersburg, FL1 decision2005–20050 recalls

FDA records 1 decision for Tohkai Precision Ind., Ltd. (Saint Petersburg, FL) in 2005: 1 510(k) clearance. All are in product code IRP (Massager, Powered Inflatable Tube). 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, physical medicine panel, where it files most

How often FDA has decided Tohkai Precision Ind., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tohkai Precision Ind., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tohkai Precision Ind., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • IRPMassager, Powered Inflatable Tube1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K040905Wellness/JoliveteTohkai Precision Ind., Ltd. · 20051cites it

What has FDA decided for it lately?

  • K040905Wellness/JoliveteTohkai Precision Ind., Ltd. · 2005

The one decision as Tohkai Precision Ind., Ltd. →

Other applicant names beginning “Tohkai”

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

Tohkai Precision Electrical Manufactory (Shenzhen)… 1