Euro Tech Sterling Roller Table
by Progressive Electrical Therapeutics
510(k) K943973
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK943973 | Date29 Sep 1994 | 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- Withdrawn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, 20 Sep 2026
The Euro Tech Sterling Roller Table is a Table, Physical Therapy, Multi Function device, classified under FDA regulation 890.5880. It is designed to support and facilitate physical therapy interventions by providing adjustable positioning and mobility for patients, often used in rehabilitation settings for therapeutic exercises and mobility training. Its multi-functional design allows for versatile applications in physical medicine, including traction, stretching, and controlled movement therapies.
This device is supplied as a reusable medical table and is intended for use in clinical environments such as physical therapy clinics or rehabilitation centers. It is not sterile and requires cleaning and maintenance between uses. The table is classified as FDA Class II, with clearance under 510(k) number K943973, and adheres to regulatory standards for physical therapy equipment. No MRI safety information is specified, and its dimensions or storage requirements are not detailed in the available data.
Other devices from Progressive Electrical Therapeutics
Questions
AI-generated answers, 20 Sep 2026
What types of physical therapy interventions can the Euro Tech Sterling Roller Table support, and how does its design help in these applications?
The Euro Tech Sterling Roller Table is designed to support a variety of physical therapy interventions, including traction, stretching, and controlled movement therapies. Its multi-functional design allows for adjustable positioning and mobility, making it versatile for rehabilitation settings. The table’s adjustable features help clinicians facilitate therapeutic exercises and mobility training by providing stable, customizable support for patients during these interventions.
Is the Euro Tech Sterling Roller Table intended for single-use or reusable applications, and what maintenance is required?
The Euro Tech Sterling Roller Table is intended for reusable applications in clinical environments like physical therapy clinics or rehabilitation centers. Since it is not sterile, it requires thorough cleaning and maintenance between uses to ensure hygiene and proper functionality. Regular maintenance will help prolong its lifespan and ensure safe, effective use for patients.
How was the Euro Tech Sterling Roller Table determined to be substantially equivalent to existing devices, and what regulatory pathway was followed?
The Euro Tech Sterling Roller Table was determined to be substantially equivalent (SE) to predicate devices through the FDA’s 510(k) review process. This classification was based on a traditional 510(k) submission, reviewed by the Physical Medicine (PM) Advisory Committee. The device was cleared under 510(k) number K943973, confirming it meets FDA standards for physical therapy tables under regulation 890.5880.
What clinical environments or specialties is the Euro Tech Sterling Roller Table primarily intended for, and why?
The Euro Tech Sterling Roller Table is primarily intended for use in clinical environments such as physical therapy clinics or rehabilitation centers. Its design aligns with the needs of Physical Medicine, as indicated by its FDA classification and regulatory pathway, making it suitable for therapeutic exercises, mobility training, and controlled movement therapies in these settings.