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Cranial Symmetry System

by Beverly Hills Prosthetics Orthotics, Inc.

510(k) K022273

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK022273 Date9 Sep 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MVA
Device Class
Class II
Regulation
21 CFR Part 882.5970
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cranial Symmetry System is an orthosis, cranial, as defined in the device data. It is a helmet designed for cranial symmetry management.

The device is supplied non-sterile and is reusable. It is intended for use in neurology-related settings. Authorisations include FDA 510(k) clearance under K022273, with product code MVA and regulation number 882.5970.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Cranial Symmetry System used for?

    The Cranial Symmetry System is a cranial orthosis helmet designed for cranial symmetry management, intended for use in neurology-related settings to support the management of head shape asymmetry.

  • Is the Cranial Symmetry System sterile or non-sterile, and is it reusable?

    The device is supplied non-sterile and is designed for reuse, meaning it can be cleaned and used multiple times following appropriate cleaning protocols as indicated by the manufacturer.

  • What regulatory authorization does the Cranial Symmetry System have?

    The Cranial Symmetry System has FDA 510(k) clearance under submission number K022273, classified as a Class II device with product code MVA and regulation number 882.5970.