Cleared Traditional

Omnispec ED1000

K210166 · Medispec, Ltd. · Physical Medicine

Jan 2023

Decision

736d

Days

Class 1

Risk

About This 510(k) Submission

K210166 is an FDA 510(k) clearance for the Omnispec ED1000, a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by Medispec, Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on January 27, 2023, 736 days after receiving the submission on January 21, 2021. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number	K210166 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 21, 2021
Decision Date	January 27, 2023
Days to Decision	736 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF