Cleared Traditional

K150436 - ComboRehab

K150436 is an FDA 510(k) clearance for ComboRehab, 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 267-day FDA review.

K150436 · Shenzhen Dongdixin Technology Co., Ltd. · Physical Medicine device
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Nov 2015
Decision
267d
Days
Class 2
Risk

K150436 is an FDA 510(k) clearance for the ComboRehab. 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 13, 2015 after a review of 267 days - an extended review cycle.

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. 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 Shenzhen Dongdixin Technology Co., Ltd. devices

FDA 510(k) Submission Details - K150436

510(k) Number K150436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2015
Decision Date November 13, 2015
Days to Decision 267 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 115d · This submission: 267d
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 K150436.
Ultrasound Therapy Workstation (XMS-UET2)
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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
SONICSTIMU COMBO THERAPEUTIC DEVICE
K120217 · Shenzhen Dongdixin Technology Co., Ltd. · Nov 2012
SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM
K121059 · Zimmer Medizinsystems GmbH · Aug 2012
SONICATOR PLUS 920
K111482 · Mettler Electronics Corp. · Aug 2011