Incare Hot/Ice System 3
by Hollister, Inc. 510(k)
Active
510(k) K915196
Overview
The Incare Hot/Ice System 3 is a hot or cold water circulating pack, a type of device used in physical medicine. It is designed to provide hot or cold therapy. The device is classified as a class 2 device.
The Incare Hot/Ice System 3 is supplied by Hollister, Inc. and has been cleared by the FDA with the clearance number K915196. The device is regulated under the regulation number 890.5720 and has a product code of ILO. It is intended for use in a medical setting, but specific details on its use, sterility, and storage are not provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK915196 | Date3 Feb 1992 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- ILO
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5720
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Other devices from Hollister, Inc.
Questions
What is the Incare Hot/Ice System 3 used for?
The Incare Hot/Ice System 3 is used to provide hot or cold therapy in a medical setting.
Is the Incare Hot/Ice System 3 a single-use device?
The available data does not specify if the Incare Hot/Ice System 3 is for single-use or reuse.
What is the regulatory classification of the Incare Hot/Ice System 3?
The Incare Hot/Ice System 3 is classified as a class 2 device, regulated under the number 890.5720 with a product code of ILO.