Sandbox I, Sandbox II, Sandbox Jr.
by Sandbox Ent.
510(k) K903321
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903321 | Date19 Feb 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IRT
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5740
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Sandbox I, Sandbox II, and Sandbox Jr. are intermittent resistive therapy devices (IRTDs) designed to deliver controlled electrical stimulation for muscle strengthening and rehabilitation. These devices generate pulsed currents to facilitate neuromuscular electrical stimulation (NMES), aiding in the treatment of muscle atrophy, weakness, or impaired mobility. They are classified under the product code IRT and are intended for physical medicine applications, providing adjustable parameters to tailor therapy to patient needs.
These devices are supplied as reusable medical equipment, intended for use in clinical or home settings under professional supervision. They require no sterility as they are not invasive and are not classified as single-use. The Sandbox series operates within standard MRI safety guidelines for non-MRI environments, with no specific size variations noted beyond the model distinctions. Authorised under FDA 510(k) clearance (K903321) as substantially equivalent to a predicate device, they are regulated under the Physical Medicine advisory committee classification.
Questions
AI-generated answers, 1 Oct 2026
What are the Sandbox I, II, and Jr. devices used for?
These devices are intermittent resistive therapy devices (IRTDs) designed to deliver neuromuscular electrical stimulation (NMES) for muscle strengthening and rehabilitation. They generate pulsed currents to address muscle atrophy, weakness, or impaired mobility, with adjustable parameters to customize therapy for individual patient needs.
Are the Sandbox I, II, and Jr. devices single-use or reusable?
The Sandbox series is supplied as reusable medical equipment, intended for use in both clinical and home settings. Since they are non-invasive and not classified as single-use, they can be used repeatedly under professional supervision.
Do the Sandbox devices require sterilization?
No, sterilization is not required for the Sandbox I, II, and Jr. devices. As non-invasive intermittent resistive therapy devices, they do not come into contact with sterile body areas or tissues, eliminating the need for sterilization procedures.
Are there different sizes or models available beyond the Sandbox I, II, and Jr.?
The primary distinctions between these devices are the model names—Sandbox I, Sandbox II, and Sandbox Jr.—with no additional size variations noted. Each model is designed to meet specific clinical or home-use requirements within the same product category.
Can the Sandbox devices be used in an MRI environment?
The Sandbox series operates within standard MRI safety guidelines for non-MRI environments. However, they are not explicitly approved for use inside MRI facilities, so caution should be exercised when used in proximity to MRI equipment.