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Delta Therm Cold Therapy System

by Deltatherm 510(k)

Active United States

510(k) K945399

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK945399 Date7 Mar 1995DecidedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
ILO
Device Class
Class II
Regulation
21 CFR Part 890.5720
Advisory Committee
Physical Medicine
FDA Decision
SN