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OPI BAND

FDA 510(k)

Class II (US FDA 510(k))

510(k) K001167

by Orthomerica Products, Inc.

Identifiers

510(k) Number
K001167 FDA 510(k)
FDA Product Code
MVA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5970 FDA 510(k)
Regulation Number
882.5970 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The OPI BAND is a cranial orthosis classified under product code MVA. It is a medical device designed to provide support and correction for cranial conditions.

The device is supplied by Orthomerica Products, Inc. and received FDA 510(k) clearance on July 7, 2000, with decision code SESE. It is classified as Class II under special controls regulation number 882.5970.

Frequently asked questions

What is the OPI Band used for?

The OPI Band is a cranial orthosis designed to provide support and correction for cranial conditions. It is classified under product code MVA and intended for medical use in addressing specific cranial abnormalities.

How is the OPI Band supplied?

The OPI Band is supplied by Orthomerica Products, Inc. It is a Class II medical device that received FDA 510(k) clearance on July 7, 2000, with decision code SESE, indicating it is substantially equivalent to other devices on the market.

What are the regulatory specifications of the OPI Band?

The OPI Band is classified under special controls regulation number 882.5970 and is a Class II device. It received FDA 510(k) clearance through the traditional review process and was reviewed by the Neurology advisory committee.

Is the OPI Band reusable or single-use?

The device data does not specify whether the OPI Band is reusable or single-use. This information would typically be found in the device's instructions for use or product labeling, which are not included in the provided data.

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: Home - Orthomerica Products, Inc., OPI BAND (K001167) — FDA 510 (k) | Innolitics, K001167 FDA 510 (k) - OPI BAND | Orthomerica Products, Inc., OPI BAND 510 (k) K001167 - FDA.report, Opi Band - Beudamed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Orthomerica Products, Inc.

Sources (1)

  • FDA 510(k) K001167 24 fields · synced Sep 24, 2026