IntelliSTIM

FDA UDI

Class II (US FDA UDI)

by EasyMed Instruments Co., Ltd.

Identity

Trade Name: IntelliSTIM FDA UDI
Generic Name: Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Device Name: IntelliSTIM BE-28E is an EMS (Electrical Neuromuscular Stimulator), which is indicated for: 1. Relaxation of muscle spasm; 2 Increasing local blood circulation and muscle re-education; 3. Prevention or retardation of disuse atrophy; 4. Prevention of venous thrombosis of the calf muscles immediately after surgery; 5.Maintaining or increasing range of motion. FDA UDI
Model / Reference: BE-28E FDA UDI
Description: IntelliSTIM BE-28E is an EMS (Electrical Neuromuscular Stimulator), which is indicated for: 1. Relaxation of muscle spasm; 2 Increasing local blood circulation and muscle re-education; 3. Prevention or retardation of disuse atrophy; 4. Prevention of venous thrombosis of the calf muscles immediately after surgery; 5.Maintaining or increasing range of motion. FDA UDI

Identifiers

Primary DI / UDI-DI: 06942808231023 FDA UDI
FDA Product Code: IPF FDA UDI
GZJ FDA UDI
GMDN Term: Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5850 FDA UDI
882.5890 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

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Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

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Premarket Exempt

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Lot / Batch Number

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Serial Number

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Expiration Date

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Manufacturing Date

FDA UDI

IntelliSTIM by EasyMed Instruments Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: EasyMed Instruments Co., Ltd.

Sources (1)

FDA UDI 47400a6d-dfd0-4656-ad92-27f9b1704c1c 34 fields · synced May 30, 2026