Cleared Traditional

K150436 - ComboRehab

K150436 is the FDA 510(k) clearance for ComboRehab by Shenzhen Dongdixin Technology Co., Ltd.. It is a Class 2 Physical Medicine device (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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 24
Devices cleared under the same product code (IMG) and FDA review panel - the closest regulatory comparables to K150436.
Ultrasound Therapy Workstation (XMS-UET2)
K244041 · Xemis Medical Technology (Shenzhen) Co., Ltd. · Oct 2025
BTL-4000
K150353 · BTL Industries, Inc. · Nov 2015
ULTRA V THERAPEUTIC ULTRASOUND
K001166 · Excel Tech. , Ltd. · Jul 2000
VECTRA COMBO
K982317 · Chattanooga Group, Inc. · Feb 1999
FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO
K982830 · Chattanooga Group, Inc. · Nov 1998
FORTE
K953614 · Chattanooga Group, Inc. · Oct 1995