STARband— 510(k) K211376

Substantially Equivalent

Orthomerica Products, Inc.

FDA 510(k) clearance K211376 for STARband, Substantially Equivalent on 2021-08-17. 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: 2021-05-04
Decision date: 2021-08-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OAN

K244056 — DOC Band 3D2025-03-17
K240466 — STARband 3D2024-03-15
K203098 — STARband, STARlight, St. Louis Band2021-04-27
K180109 — STARband, STARlight, St. Louis Band2018-03-01
K161138 — St. Louis Band2016-07-20

More clearances from Orthomerica Products, Inc.

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