510(k) Report

FDA applicant

Thermo Body Wrap Systems, Inc.

Clearwater, FL1 decision1988–19880 recalls

FDA records 1 decision for Thermo Body Wrap Systems, Inc. (Clearwater, FL) in 1988: 1 510(k) clearance. All are in product code IRT (Pad, Heating, Powered). 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 Thermo Body Wrap Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Thermo Body Wrap Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Thermo Body Wrap Systems, Inc.’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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Other applicant names beginning “Thermo”

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