Cleared Traditional

K230385 - Ballancer Platinum (1222) (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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 149
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K230385.
Air Pressure Therapy System (VU-IPC8M)
K253064 · Xiamen Weiyou Intelligent Technology Co., Ltd. · Apr 2026
Hot and Cold Compression System (A02-C-032)
K252386 · Chengdu Cryo-Push Medical Technology Co.,Ltd · Apr 2026
Cryopush Cold Compression Device (A02-P-001)
K253076 · Chengdu Cryo-Push Medical Technology Co.,Ltd · Apr 2026
Hand Massager (SM004D)
K251622 · Ningbo Zhenhai Yihao Electronic Technology Co., Ltd. · Jan 2026
Air Compression Therapy Device (ST-504)
K251662 · Shenzhen Future Electronic Co., Ltd. · Nov 2025
AIR COMPRESSION BOOTS 1018195,1018196
K251531 · Merchsource, LLC · Oct 2025