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Ortoma Treatment Solution - OTS

by Ortoma AB Sweden 510(k)

510(k) K181449

Product code OLO

Overview

The Ortoma Treatment Solution - OTS is a device used in neurology. It is substantially equivalent to a predicate device as determined by FDA 510(k) clearance.

The device was manufactured by Ortoma AB and received FDA 510(k) clearance via the traditional pathway on September 19, 2018. It is identified by K-number K181449 and product code OLO.

Summary written by AI from registry data, 23 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181449 Date19 Sep 2018ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
OLO
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Ortoma AB

See all devices from Ortoma AB →

Questions

  • What is the Ortoma Treatment Solution - OTS used for?

    The Ortoma Treatment Solution - OTS is a device used in neurology, as stated in its description. It was determined to be substantially equivalent to a predicate device through FDA 510(k) clearance, indicating it shares similar intended use and technological characteristics with a legally marketed device.

  • Who manufactures the Ortoma Treatment Solution - OTS and where are they located?

    The device is manufactured by Ortoma AB, located at Vadursgatan 5, Goteborg, S-41250, Sweden (country code SE). This information is provided in the manufacturer and address fields of the device data.

  • When did the Ortoma Treatment Solution - OTS receive FDA 510(k) clearance and what is its K-number?

    The device received FDA 510(k) clearance via the traditional pathway on September 19, 2018, and is identified by K-number K181449. These details are explicitly stated in the authorizations and specifications sections.

  • What product code is assigned to the Ortoma Treatment Solution - OTS?

    The device is assigned product code OLO, as specified in the specifications section. This code is used by the FDA to categorize the device within its regulatory framework.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K181449 24 fields · synced 22 Oct 2026