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Orthoderm Convertible

FDA 510(k)

Class II (US FDA 510(k))

510(k) K894353

by Health Products, Inc.

Identifiers

510(k) Number
K894353 FDA 510(k)
FDA Product Code
IOQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5170 FDA 510(k)
Regulation Number
890.5170 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Orthoderm Convertible is a bed designed for flotation therapy, which is a type of physical medicine treatment. This device is intended to provide support and comfort during therapeutic sessions by utilizing flotation technology.

The Orthoderm Convertible is supplied as a non-sterile device and is available in various sizes. It is regulated under FDA 510K clearance with device class 2 and product code IOQ. The device is manufactured by Health Products, Inc. and has multiple registration numbers associated with it.

Frequently asked questions

What is the Orthoderm Convertible used for?

The Orthoderm Convertible is a bed designed specifically for flotation therapy, which is a type of physical medicine treatment. It provides support and comfort during therapeutic sessions by utilizing flotation technology.

Is the Orthoderm Convertible sterile and how is it supplied?

The Orthoderm Convertible is supplied as a non-sterile device and is available in various sizes to accommodate different patient needs. It is not supplied in a sterile condition.

What is the regulatory status of the Orthoderm Convertible?

The Orthoderm Convertible is regulated under FDA 510K clearance with device class 2 and product code IOQ. It has been determined to be substantially equivalent to other devices in its class.

Can the Orthoderm Convertible be reused or is it single-use?

The device data does not specify whether the Orthoderm Convertible is designed for single-use or multiple uses. The product description only indicates it is a non-sterile device available in various sizes.

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

United States Active

FDA_510K

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Manufacturer

Manufacturer
Health Products, Inc.

Sources (1)

  • FDA 510(k) K894353 24 fields · synced Sep 23, 2026