Concept CCT-5200 Thermal Therapy System
by Concept, Inc. 510(k)
Active
510(k) K884255
Overview
The Concept CCT-5200 Thermal Therapy System is a Pack, Hot or Cold, Water Circulating device, classified under FDA product code ILO. It delivers controlled thermal therapy through circulating water, enabling both heating and cooling applications for therapeutic purposes in physical medicine settings.
This system is intended for use in clinical environments and is supplied as a reusable medical device. It operates under traditional FDA clearance (510K) and adheres to special controls for Class II devices. The device requires proper maintenance and storage as per manufacturer guidelines to ensure safe and effective thermal therapy delivery.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884255 | Date8 Nov 1988 | 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- Withdrawn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 Concept, Inc.
Questions
What types of thermal therapy can the Concept CCT-5200 deliver, and where is it primarily used?
The Concept CCT-5200 Thermal Therapy System delivers both heating and cooling therapy through circulating water, making it versatile for applications like physical medicine treatments. It is designed for clinical environments, such as physical therapy clinics or rehabilitation centers, where controlled thermal therapy is applied to manage pain, reduce inflammation, or improve mobility.
Is the Concept CCT-5200 a single-use or reusable device, and what does this mean for maintenance?
The Concept CCT-5200 is a reusable medical device, meaning it is intended for repeated use across multiple patients after proper cleaning, disinfection, and maintenance. Since it is reusable, adherence to manufacturer guidelines for maintenance and storage is critical to ensure safe and effective operation, including regular servicing to prevent wear or malfunction.
How is the device regulated, and what does this imply for purchasing or clinical use?
The Concept CCT-5200 is classified under FDA product code ILO and has received traditional 510K clearance, meaning it meets FDA standards for Class II devices in physical medicine. This implies it has undergone regulatory review for safety and effectiveness, but purchasers or clinicians should confirm compliance with the manufacturer’s instructions and any applicable local regulations to ensure proper use.
Are there different models or sizes available for the Concept CCT-5200, and how might this affect selection?
The provided data lists multiple registration numbers, which may correspond to different configurations or accessories for the CCT-5200 system, but no specific details on distinct models or sizes are explicitly described. For precise sizing or model selection, refer to the manufacturer’s documentation or contact Concept, Inc. directly, as this could impact compatibility with clinical workflows or patient needs.
What should clinicians or facility staff consider when storing the Concept CCT-5200?
Since the device is reusable, proper storage is essential to maintain its functionality and hygiene. The manufacturer’s guidelines likely specify conditions such as temperature, humidity, and protection from contamination. Staff should store it in a clean, dry environment away from direct sunlight or sources of moisture to prevent damage or degradation, ensuring it remains ready for safe and effective use when needed.