Stimulation System PR36

• FDA 510(k) K232786 decided 16 May 2024 Active
• FDA GUDID UDI-DI 06944413866133 listed 15 May 2026 Listed

1. 16 May 2024 Cleared FDA 510(k) K232786
2. 15 May 2026 Listed FDA GUDID 06944413866133

Trade name

Stimulation System

Generic name

Physical therapy transcutaneous neuromuscular electrical stimulation system

Model / reference

PR36

Primary DI / UDI-DI

06944413866133

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).

• ESCOTEK EST 210, HIGH VOLTAGE ELECTRO GALVANIC STI by Nor-Am Patient Care Products, Inc.
• ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000 by BioMedical Life Systems Inc.
• SOKEN(TM) ELECTRONIC MUSCLE STIMULATOR by Rehab Medical Specialties, Inc.
• ORTHOTRON MUSCLE STIMULATOR MK II DC by Hodgkinson & Corby, Ltd.
• ELECTRONIC MUSCLE STIMULATOR by Beverly Hills Exercise Equipment
• RICH-MAR BP-2000 ELECTRICAL MUSCLE STIMULA. UNIT by Rich-Mar Corp.
• BX-400S by Bloomex International, Inc.
• GALVANATOR, MODEL 770 by Avra Corp.
• MINITONE by Bloomex International, Inc.
• ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT by Eswallow USA

• Remote Event Marker 02.01.210095

  Class II

  FDA 510(k) K241882 Active Cleared 27 Aug 2025 GUDID on market

• Ultrasound Transducer US-SF

  Class II

  CE/MDR FDA 510(k) K241882 Active Cleared 27 Aug 2025 +1authorizations

• Ultrasound Transducer US-TF

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  CE/MDR FDA 510(k) K241882 Active Cleared 27 Aug 2025 +1authorizations

• Fetal & Maternal Module DECG-IF

  Class II

  FDA 510(k) K241882 Active Cleared 27 Aug 2025 GUDID on market

See all devices from Edan Instruments, Inc. →