Cleared Traditional

ManaSport

K210284 · Manamed, Inc. · Physical Medicine

Apr 2022

Decision

448d

Days

Class 2

Risk

About This 510(k) Submission

K210284 is an FDA 510(k) clearance for the ManaSport, a Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMI), submitted by Manamed, Inc. (Las Vegas, US). The FDA issued a Cleared decision on April 26, 2022, 448 days after receiving the submission on February 2, 2021. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K210284 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 2021
Decision Date	April 26, 2022
Days to Decision	448 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement

Device Classification

Product Code	IMI — Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5300