Hot/Ice Dual Function Equipment
FDA 510(k) K871962 · Thermo Temp, Inc.
510(k) numberK871962
Submission
- Device name
- Hot/Ice Dual Function Equipment
- Applicant
- Thermo Temp, Inc.
Tampa, FL, US - Received
- May 20, 1987
- Decision date
- June 26, 1987
- Decision
- Substantially Equivalent (SESE)
- 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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| 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 Hot/Ice Dual Function Equipment cleared by the FDA?
Hot/Ice Dual Function Equipment (K871962) received a 510(k) decision of Substantially Equivalent on June 26, 1987, 37 days after the submission was received.
What is the product code of K871962?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.