Cleared Traditional

Ballancer Platinum (1222) (K230385) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230385 · Mego Afek · Physical Medicine device
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Apr 2023
Decision
49d
Days
Class 2
Risk

K230385 is an FDA 510(k) clearance for the Ballancer Platinum (1222). Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Mego Afek (Kibbuts Afek, IL). The FDA issued a Cleared decision on April 4, 2023 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mego Afek devices

Submission Details

510(k) Number K230385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2023
Decision Date April 04, 2023
Days to Decision 49 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 115d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
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 - IRP Massager, Powered Inflatable Tube

All 95
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K230385.
Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401)
K230500 · Jiangsu Maxf Electric Appliance Co., Ltd. · Oct 2023
Therm-X
K231912 · Zenith Technical Innovations · Jul 2023
LF900
K231437 · Daesung Maref Co., Ltd. · Jul 2023
Air Compression Leg Massager (model: EMK-701)
K222991 · Xiamen Emoka Health Science & Technology Co., Ltd. · Mar 2023
Leg and Foot Air Wave Pressure Therapy Device
K223464 · Zhangzhou Easepal Innovation CO , Ltd. · Mar 2023
Cryo-Thermo Compression Device (FGK002)
K222136 · Suzhou Microport Rehabtech (Group) Co., Ltd. · Mar 2023