Cleared Traditional

K120217 - SONICSTIMU COMBO THERAPEUTIC DEVICE

K120217 is an FDA 510(k) clearance for SONICSTIMU COMBO THERAPEUTIC DEVICE, manufactured by Shenzhen Dongdixin Technology Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IMG cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K120217 · Shenzhen Dongdixin Technology Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
302d
Days
Class 2
Risk

K120217 is an FDA 510(k) clearance for the SONICSTIMU COMBO THERAPEUTIC DEVICE. Classified as Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (product code IMG), Class II - Special Controls.

Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 21, 2012 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5860 - 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. Elevated predicate reliance profile. 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 Shenzhen Dongdixin Technology Co., Ltd. devices

FDA 510(k) Submission Details - K120217

510(k) Number K120217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2012
Decision Date November 21, 2012
Days to Decision 302 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 115d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMG Device Classification - Class 2, Special Controls

Product Code IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5860
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 - IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

All 40
Devices cleared under the same product code (IMG) and FDA review panel - the closest regulatory comparables to K120217.
OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System
K153559 · Accelerated Care Plus (Acp) · Aug 2016
BTL-4000
K150353 · BTL Industries, Inc. · Nov 2015
ComboRehab
K150436 · Shenzhen Dongdixin Technology Co., Ltd. · Nov 2015
SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM
K121059 · Zimmer Medizinsystems GmbH · Aug 2012
SONICATOR PLUS 920
K111482 · Mettler Electronics Corp. · Aug 2011
CT2011 SONICSTIMU PAIN RELIEF DEVICE
K092627 · Shenzhen Dongdixin Technology Co., Ltd. · Jan 2010