K955808 is the FDA 510(k) clearance record for DYNA T-2000 PHYSICAL THERAPY SYSTEM, a class II device, cleared for Thermia, Inc. on 1997-11-03 under FDA product code IMB (Cabinet, Moist Steam). FDA records list one 510(k) clearance for Thermia, Inc. As of 2026-09-10 , FDA records show no recalls naming K955808.
Clearance record Decision date 1997-11-03 Received 1995-12-22 (682 days to decision) Product code IMB Cabinet, Moist SteamRegulation 21 CFR 890.5250 Device class Class II Review panel Physical Medicine Applicant Thermia, Inc. 4200 W. 76th St., Edina MN 510(k) summary Statement Third party review No
Clearances, product code IMB Trailing 12 months FDA records hold no clearances under product code IMB in the trailing twelve months.
FDA records show no clearances under product code IMB in the twelve months to October 2026. Show the numbers FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
Product code IMB
Z-1605-2009 A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to... Sybaritic, Inc / initiated 2007-06-22 / 10 Z-1604-2009 A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to... Sybaritic, Inc / initiated 2007-06-22 / 86 Z-1603-2009 A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to... Sybaritic, Inc / initiated 2007-06-22 / 29 Z-1602-2009 A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to... Sybaritic, Inc / initiated 2007-06-22 / 238 units Z-1245-2009 Sybaritic conducted a recall on the Hydration Station 806 because of the potential for hot water to spurt through steam ports... Sybaritic, Inc / initiated 2007-05-15 / 370
MDM coverage of this record lists here, newest first.
About this record Sourced from the FDA 510(k) premarket notification database, ingested from openFDA. MDM adds the decision time in days, the product code cross-link, recalls sharing that product code, and MDM coverage of the record.
Predicate devices are not listed. The openFDA 510(k) endpoint does not publish predicate references, so MDM does not assert them. Where a 510(k) summary exists, the FDA PDF is linked above and names the predicate itself.
Data as of 2026-09-28 , the FDA export date for this dataset. Page last changed 2026-09-05 . View this record on fda.gov ↗ (opens on fda.gov)
