Identifiers
- 510(k) Number
- K160358 FDA 510(k)
- FDA Product Code
- FLL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2910 FDA 510(k)
- Regulation Number
- 880.2910 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DT-100 is a Hospital Bed designed for general hospital use, providing adjustable support and positioning for patients. It is classified under product code FLL in the FDA’s nomenclature system and is intended for clinical environments requiring patient mobility and comfort.
Supplied as a reusable device, the DT-100 is intended for use in hospital settings and is regulated under a Traditional 510(k) clearance (K160358). It is manufactured by Mediana Co., Ltd., based in Wonju-Si, South Korea, and adheres to FDA standards for substantial equivalence in hospital bed functionality.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160358 | Class II | Active |
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Manufacturer
- Manufacturer
- Mediana.CO.LTD
- FDA Applicant
- Mediana Co., Ltd.
Sources (1)
- FDA 510(k) K160358 24 fields · synced Sep 19, 2026