Identifiers
- 510(k) Number
- K152228 FDA 510(k)
- FDA Product Code
- JOW 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)
The Hydroven 12 is a system comprised of an intelligent pump and a range of multi-chamber arm and leg garments. It is capable of delivering three types of treatment options. The device is classified as a Sleeve, Limb, Compressible, and is used in the Cardiovascular medical specialty.
The Hydroven 12 system is supplied with 100% Latex Free garments and is intended for use under the direction of a physician. The device has been authorized with an FDA 510K clearance, with a regulation number of 870.5800. The system includes a pump and various garments, including arm, leg, and insert garments, which are designed for use with the Hydroven 12 pump only.
Frequently asked questions
What is the Hydroven 12 system used for?
The Hydroven 12 system is used in the Cardiovascular medical specialty under the direction of a physician.
What type of garments are supplied with the Hydroven 12 system?
The Hydroven 12 system is supplied with 100% Latex Free garments, including arm, leg, and insert garments.
Is the Hydroven 12 system intended for single or multiple uses?
The device data does not specify whether the Hydroven 12 system is for single or multiple uses, but it is designed for use with the Hydroven 12 pump only.
What is the regulatory classification of the Hydroven 12 system?
The Hydroven 12 system is classified as a Sleeve, Limb, Compressible, with a regulation number of 870.5800.
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. Sources consulted: Hydroven 12 - Huntleigh Healthcare - US -, PDF INSTRUCTIONS FOR USE Hydroven 12 Hydroven 12 LymphAssist, PDF 316901-8 Hydroven 12 Garments IFU - huntleigh-diagnostics.com, PDF 316901-10 Hydroven 12 Garments IFU - huntleigh-diagnostics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152228 | Class II | Active |
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Manufacturer
- Manufacturer
- Huntleigh Healthcare , Ltd.
Sources (1)
- FDA 510(k) K152228 24 fields · synced Oct 6, 2026