Handiflex
510(k) K971046
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK971046 | Date16 Sep 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JFB
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5880
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Handiflex Table, Physical Therapy, Multi Function is a multi-functional physical therapy table designed for use in physical medicine settings. It is classified as a Class II medical device under FDA regulations and is intended for therapeutic interventions, including patient positioning and support during rehabilitation or treatment procedures. The device is engineered to provide adjustable features to accommodate various clinical needs, such as elevation, tilt, and modular attachments for enhanced functionality.
This device is supplied as a reusable medical instrument and is intended for use in clinical environments such as physical therapy clinics or rehabilitation centers. It is regulated under the FDA’s 510(k) clearance process, with a clearance date of September 16, 1997, under the product code JFB. The table is not specified as single-use or sterile upon delivery but is designed for repeated use with appropriate cleaning and maintenance procedures. No MRI safety information is provided in the available data.
Questions
AI-generated answers, 1 Oct 2026
What is the Handiflex Multi-Function Physical Therapy Table used for?
The Handiflex Multi-Function Physical Therapy Table is designed for therapeutic interventions in physical medicine settings. It provides adjustable features such as elevation, tilt, and modular attachments to support patient positioning and rehabilitation procedures. This versatility makes it suitable for a range of clinical needs, including physical therapy and treatment sessions.
Is the Handiflex Table reusable or single-use?
The Handiflex Table is intended for reusable clinical use. It is not supplied sterile and requires proper cleaning and maintenance between uses to ensure hygiene and functionality. This design aligns with its classification as a reusable medical instrument in physical therapy environments.
What adjustable features does the Handiflex Table offer?
The Handiflex Table is engineered with adjustable features such as elevation and tilt mechanisms, along with modular attachments. These features allow clinicians to customize the table’s configuration to meet specific patient needs during rehabilitation or treatment, enhancing its versatility in physical therapy settings.
How is the Handiflex Table regulated by the FDA?
The Handiflex Table is classified as a Class II medical device and has undergone FDA’s 510(k) clearance process. It was cleared on September 16, 1997, under product code JFB, with a decision confirming it is substantially equivalent to a predicate device. This regulatory pathway ensures its compliance with safety and performance standards for physical therapy tables.
What types of clinical environments is the Handiflex Table intended for?
The Handiflex Table is specifically designed for use in clinical settings such as physical therapy clinics and rehabilitation centers. Its multi-functional design supports therapeutic interventions, patient positioning, and support during rehabilitation procedures, making it ideal for environments focused on physical medicine and recovery.