Cleared Traditional

ManaSport+

K222098 · Manamed, Inc. · Physical Medicine

Mar 2023

Decision

233d

Days

Class 2

Risk

About This 510(k) Submission

K222098 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 March 8, 2023, 233 days after receiving the submission on July 18, 2022. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K222098 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 2022
Decision Date	March 08, 2023
Days to Decision	233 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

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