meddevicedb.com FDA Device Reference

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))

DEN240021 Class II Direct
Decision Date
2025-04-09
Sponsor / Applicant
Active Protective Technologies, Inc.

Technical Specification

510(k) Submission ID DEN240021
Product Code SEC
Medical Specialty / Panel Physical Medicine
Regulation Citation 21 CFR 890.3780
Decision Date 2025-04-09
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

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)) received FDA 510(k) clearance under submission number DEN240021, sponsored by Active Protective Technologies, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2025-04-09.

Classification & Regulation

This clearance is catalogued under FDA product code SEC and 21 CFR 890.3780, within the Physical Medicine review panel as a Class II device.