Stimulation System PR4 Pro

• FDA 510(k) K232786 decided 16 May 2024 Active
• FDA GUDID UDI-DI 06944413866157 listed 15 May 2026 Listed

1. 16 May 2024 Cleared FDA 510(k) K232786
2. 15 May 2026 Listed FDA GUDID 06944413866157

Trade name

Stimulation System

Generic name

Physical therapy transcutaneous neuromuscular electrical stimulation system

Model / reference

PR4 Pro

Primary DI / UDI-DI

06944413866157

510(k) Number

K232786 ↗

FDA product code

IPF, GZJ

GMDN term

Physical therapy transcutaneous neuromuscular electrical stimulation system

Device class

Class II

Regulation number

890.5850, 882.5890

GUDID distribution status

In Commercial Distribution

MRI safety

MR Unsafe

Other devices filed under FDA product code IPF (Stimulator, Muscle, Powered).

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• InMode System with Tone Applicator by InMode, Ltd.
• MOD. 3127 NEUROMUSCULAR STIMULATOR by MEDTRONIC VASCULAR, INC.
• geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators by Firstkind Limited
• THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P) by Myo/Kinetic Systems, Inc.
• VECTRA NEO CLINICAL THERAPY SYSTEM by DJO, LLC
• 4000+ by U.S. Therapy Products, Inc.
• LT3000 Combo Stimulator, LT3001 TENS Stimulatory, LT3002 EMS Stimulator by Shenzhen Dongdixin Technology Co., Ltd.
• ELECTRONIC MUSCLE EXERCISER by Bloomex International, Inc.

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See all devices from Edan Instruments, Inc. →