Granstand
510(k) K911608
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK911608 | Date23 Apr 1991 | 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- Withdrawn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
- IPL
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3900
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Granstand III Modular Standing System is a Wheelchair, Standup device designed to assist individuals in achieving an upright standing position from a seated wheelchair. It provides modular support for both children and adults, enabling customizable configurations to accommodate varying growth and mobility needs while facilitating transfers and standing activities.
This device is supplied as a reusable, non-sterile modular system intended for use in physical medicine settings, such as rehabilitation centers. It is classified under Device Class II (regulation number 890.3900) and cleared via FDA 510K (K911608) under the Physical Medicine advisory committee. Multiple configurations are available, as indicated by the listed FEI numbers, ensuring adaptability for different user requirements.
Questions
AI-generated answers, 19 Sep 2026
What types of users can benefit from the Granstand III Modular Standing System, and how does it adapt to their needs?
The Granstand III is designed for both children and adults who require assistance transitioning from a seated wheelchair to a standing position. Its modular design allows for customizable configurations to accommodate varying growth stages and mobility levels, making it suitable for long-term use in rehabilitation settings.
Is the Granstand III Modular Standing System intended for single-use or reusable applications, and where would it typically be used?
The Granstand III is explicitly supplied as a reusable, non-sterile modular system. It is intended for use in physical medicine settings, such as rehabilitation centers, where multiple patients may require assistance with standing transfers over time.
How do I determine which configuration of the Granstand III is best suited for a specific patient?
The Granstand III offers multiple configurations, each represented by unique FEI numbers (e.g., 3014653196, 3004908349). These variations ensure adaptability to different user requirements, including height, weight, and mobility needs. Consulting with a physical medicine specialist or occupational therapist can help select the appropriate model for a patient’s specific case.
What regulatory pathway was followed for the Granstand III, and what does that mean for its use in clinical settings?
The Granstand III was cleared via an FDA 510(k) submission (K911608) under the Physical Medicine advisory committee, classified as Device Class II (890.3900). This means it has undergone FDA review to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and effectiveness standards for use in physical medicine rehabilitation settings.
Are there any special storage requirements for the Granstand III Modular Standing System?
Since the Granstand III is a reusable, non-sterile modular system, it should be stored in a clean, dry environment to prevent contamination or damage. Proper maintenance, including cleaning between uses, is recommended to ensure longevity and hygiene in clinical settings.