STARband, STARlight, St. Louis Band— 510(k) K180109

Name: FDA 510(k) clearance K180109
Creator: U.S. Food and Drug Administration
Published: 2018-03-01

Substantially Equivalent

Orthomerica Products, Inc.

FDA 510(k) clearance K180109 for STARband, STARlight, St. Louis Band, Substantially Equivalent on 2018-03-01. Applicant: Orthomerica Products, Inc.. Device class: 2.

Clearance details

Applicant: Orthomerica Products, Inc.
Product code: Code OAN
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2018-01-16
Decision date: 2018-03-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OAN

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K244056 — DOC Band 3D2025-03-17
K240466 — STARband 3D2024-03-15
K211376 — STARband2021-08-17
K203098 — STARband, STARlight, St. Louis Band2021-04-27
K161138 — St. Louis Band2016-07-20

More clearances from Orthomerica Products, Inc.

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K223238 — STARband 3D2023-04-20
K151979 — STARband, STARlight2015-09-18
K151147 — STARband, STARlight2015-07-01
K142141 — STARBAND, STARLIGHT2015-04-23
K141842 — STARBAND, STARLIGHT2014-10-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.