Thermotek H-300
FDA 510(k) K945853 · Thermotek, Inc.
510(k) numberK945853
Submission
- Device name
- Thermotek H-300
- Applicant
- Thermotek, Inc.
Carrollton, TX, US - Received
- October 31, 1994
- Decision date
- October 5, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- ILO – Pack, Hot Or Cold, Water Circulating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5720
- Specialty
- Physical Medicine
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| K040317 | Ivc SystemILO · Traditional | Mark H. Friedman | 05/07/2004SE |
| K973023 | Incare Hot/Ice System Foot/Ankle BlanketILO · Traditional | Hollister, Inc. | 11/03/1997SE |
| K970197 | HTP-1500 Localized Heat Therapy PumpILO · Traditional | Adroit Medical Systems, Inc. | 09/10/1997SE |
| K964799 | Artrotherm Cryotherapy and ThernotherapyILO · Traditional | Ormed GmbH | 08/29/1997SE |
| K964354 | Artocool-S Water Circulating Cold PackILO · Traditional | Ormed GmbH | 08/29/1997SE |
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Questions and answers
When was Thermotek H-300 cleared by the FDA?
Thermotek H-300 (K945853) received a 510(k) decision of Substantially Equivalent for Some Indications on October 5, 1995, 339 days after the submission was received.
What is the product code of K945853?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.