Cleared Traditional

K222098 - ManaSport+

K222098 is an FDA 510(k) clearance for ManaSport+, manufactured by Manamed, Inc.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K222098 · Manamed, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
233d
Days
Class 2
Risk

K222098 is an FDA 510(k) clearance for the ManaSport+. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Manamed, Inc. (Las Vegas, US). The FDA issued a Cleared decision on March 8, 2023 after a review of 233 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5300 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Manamed, Inc. devices

FDA 510(k) Submission Details - K222098

510(k) Number K222098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 115d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMI Device Classification - Class 2, Special Controls

Product Code IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

All 35
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K222098.
Ultrasound Stimulator
K240788 · Jkh Health Co., Ltd. · Jun 2025
Sonopuls 190
K230472 · Enraf-Nonius, B.V. · Oct 2023
ManaSport
K210284 · Manamed, Inc. · Apr 2022
Sonomed IV, Sonomed V
K202788 · Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto · Dec 2021
UltraTENS
K142976 · Shenzhen Dongdixin Technology Co., Ltd. · Aug 2015
SONICATOR 740, MODEL ME 740
K053546 · Mettler Electronics Corp. · May 2006