Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL))
by Active Protective Technologies, Inc.
De Novo DEN240021
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG | NumberDEN240021 | Date9 Apr 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- De Novo Number
- FDA Product Code
- SEC
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3780
- Advisory Committee
- Physical Medicine
- FDA Decision
- DENG De Novo granted
Overview
AI-generated summary, 1 Oct 2026
The Tango Belt is a wearable fall injury prevention device classified as a Wearable Hip Protection Device. It is designed to reduce the risk of hip dislocation or fracture in older adults by providing external support during falls. The device is intended for use by individuals aged 65 and older who are at risk of major hip injuries due to falls. It operates as a passive protective mechanism without active monitoring or intervention beyond its physical structure.
The Tango Belt is supplied in five adjustable sizes (XS, S, M, L, XL) and is intended for single-use or reusable applications, depending on clinical guidelines. It is not classified as sterile and is intended for use in home or clinical settings where fall risk is assessed. The device has received FDA 510(k) clearance under the classification of a Class II medical device (Device Class: 2, Regulation Number: 890.3780). No MRI safety information or specific storage requirements are noted in the regulatory data.
Other devices from Active Protective Technologies, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Tango Belt designed to do?
The Tango Belt is a wearable hip protection device intended to reduce the risk of hip dislocation or fracture during falls. It provides external support to the hip area as a passive protective mechanism, meaning it relies on its physical structure rather than active monitoring or intervention. This makes it suitable for older adults aged 65 and older who are at higher risk of major hip injuries from falls.
How many sizes are available, and how do I choose the right one?
The Tango Belt comes in five adjustable sizes: XS (Model SAS-001-01), S (Model SAS-001-02), M (Model SAS-001-03), L (Model SAS-001-04), and XL (Model SAS-001-05). To select the correct size, measure the user’s waist circumference and hip width, then match it to the manufacturer’s sizing guide. Proper fit ensures optimal protection and comfort during use.
Is the Tango Belt reusable or single-use?
The Tango Belt is designed for either single-use or reusable applications, depending on clinical guidelines and usage conditions. If the device is damaged, soiled, or no longer provides adequate support, it should be replaced. Reuse is permitted only if the device remains intact and meets hygiene standards for continued use.
Is the Tango Belt sterile?
No, the Tango Belt is not classified as a sterile device. It is intended for use in both home and clinical settings where fall risk is assessed, but it does not require sterile conditions. Proper hygiene practices, such as handwashing before and after use, should be followed to maintain cleanliness.
Are there any special storage requirements for the Tango Belt?
The regulatory data does not specify any special storage requirements for the Tango Belt. However, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity. If stored for extended periods, check for damage or wear before use.