Product code IRQ
- Device name
- Unit, Heating, Powered
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.5950
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050524 | EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 | Marda Medical, Inc. | 2005-09-14 |
| K950350 | THEMALATOR. MODELS T-4-S, T-8-S, ETC. | Whitehall/Div Columbus Mckennon Corp. | 1995-03-24 |
| K924023 | FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917 | Ferno | 1993-04-14 |
| K880644 | ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) | Fred Sammons, Inc. | 1988-05-06 |
| K861340 | R1750 AND R1424 POWERED HEATING UNITS | Tri W-G, Inc. | 1986-05-02 |
| K832177 | PULSAIR MODEL SP-1 | Thermowave Medical Device Corp. | 1983-12-09 |
| K801625 | THERMOLATOR HEATING UNIT | Tru-Eze Mfg. Co., Inc. | 1980-07-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07898966442933 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2025-02-25 |
| 07898966442964 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2025-02-25 |
| 00092237626009 | HydraTherm | Drive Devilbiss Healthcare | 2024-05-14 |
| 00092237626016 | HydraTherm | Drive Devilbiss Healthcare | 2024-05-14 |
| 00092237625552 | HydraTherm | Drive Devilbiss Healthcare | 2024-03-06 |
| 00092237625545 | HydraTherm | Drive Devilbiss Healthcare | 2024-03-06 |
| 00092237625569 | HydraTherm | Drive Devilbiss Healthcare | 2024-03-06 |
| 00092237625576 | HydraTherm | Drive Devilbiss Healthcare | 2024-03-06 |
| 00092237625583 | HydraTherm | Drive Devilbiss Healthcare | 2024-03-06 |
| 00092237625590 | HydraTherm | Drive Devilbiss Healthcare | 2024-03-06 |
| 00092237625606 | HydraTherm | Drive Devilbiss Healthcare | 2024-03-06 |
| 00092237625613 | HydraTherm | Drive Devilbiss Healthcare | 2024-03-06 |
| 00092237625620 | HydraTherm | Drive Devilbiss Healthcare | 2024-03-06 |
| 04719875347023 | VADI | VADI MEDICAL TECHNOLOGY CO., LTD. | 2023-07-20 |
| 04719875347030 | VADI | VADI MEDICAL TECHNOLOGY CO., LTD. | 2023-07-20 |
| 04719894380384 | VADI | VADI MEDICAL TECHNOLOGY CO., LTD. | 2023-07-20 |
| 08809520550222 | Relief Pak 6 pack heating Unit | KARIS Co.,Ltd | 2023-01-25 |
| 08809520550253 | Relief Pak 24 pack heating Unit | KARIS Co.,Ltd | 2023-01-25 |
| 08809520550246 | Relief Pak 12 pack heating Unit | KARIS Co.,Ltd | 2023-01-25 |
| 08809520550239 | Relief Pak 8 pack heating Unit | KARIS Co.,Ltd | 2023-01-25 |
| 08809520550215 | Relief Pak 4 pack heating Unit | KARIS Co.,Ltd | 2023-01-25 |
| 00888912288729 | CHATTANOOGA | DJO, LLC | 2022-11-01 |
| 00888912278058 | CHATTANOOGA | DJO, LLC | 2022-11-01 |
| 00888912278010 | CHATTANOOGA | DJO, LLC | 2022-11-01 |
| 00888912021463 | CHATTANOOGA | DJO, LLC | 2022-11-01 |
| 00888912021166 | CHATTANOOGA | DJO, LLC | 2022-11-01 |
| 06438408002175 | Inion® Universal instruments | Inion Oy | 2020-05-08 |
| 06438408002144 | Inion® Universal instruments | Inion Oy | 2020-05-08 |
| 06438408002106 | Inion® Universal instruments | Inion Oy | 2020-05-08 |
| 06438408000331 | Inion® Universal instruments | Inion Oy | 2020-05-08 |