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))
FDA 510(k) clearance DEN240021 · decided 2025-04-09
Clearance details
- K-number
- DEN240021
- Device name
- 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))
- Applicant
- Active Protective Technologies, Inc.
- Decision
- Unknown
- Date received
- 2024-05-16
- Decision date
- 2025-04-09
- Days to decision
- 328 days
- Clearance type
- Direct
- Product code
- SEC
- Device class
- 2
- Regulation number
- 890.3780
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Fort Washington, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.