← Back to catalogue
ActiveCare+SFT - ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx
FDA 510(k)Class II (US FDA 510(k))
510(k) K142728
Identifiers
- 510(k) Number
- K142728 FDA 510(k)
- FDA Product Code
- JOW FDA 510(k)
- Models / Variants
- ActiveCare+SFT FDA 510(k)ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5800 FDA 510(k)
- Regulation Number
- 870.5800 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
ActiveCare+SFT - ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx by Medical Compressions System (Dbn) , Ltd. — Class II — FDA_510K…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142728 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medical Compressions System (Dbn) , Ltd.
Sources (1)
- FDA 510(k) K142728 24 fields · synced Jun 18, 2026