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Golden State Medical HD Combo

FDA UDI

Class II (US FDA UDI)

by International Trade Group Inc

Identity

Trade Name
Golden State Medical HD Combo FDA UDI
Generic Name
Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Device Name
GSM HD Combo Transcutaneous Electrical Nerve Stimulation (TENS): The device is intended for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from exercise and/or normal household and work activities. GSM HD Combo Neuromuscular electrical stimulation (NMES): The device is intended to stimulate muscles in order to facilitate and improve muscle performance. FDA UDI
Model / Reference
ECS322P FDA UDI
Description
GSM HD Combo Transcutaneous Electrical Nerve Stimulation (TENS): The device is intended for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from exercise and/or normal household and work activities. GSM HD Combo Neuromuscular electrical stimulation (NMES): The device is intended to stimulate muscles in order to facilitate and improve muscle performance. FDA UDI

Identifiers

Primary DI / UDI-DI
00860001588309 FDA UDI
FDA Product Code
NGX FDA UDI
NUH 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
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Height — 128 Millimeter FDA UDI
Width — 67 Millimeter FDA UDI
Depth — 25 Millimeter FDA UDI
Weight — 0.12 Kilogram FDA UDI

Category: Physical therapy transcutaneous neuromuscular electrical stimulation system

Golden State Medical HD Combo by International Trade Group Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Physical therapy transcutaneous neuromuscular electrical stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
International Trade Group Inc

Sources (1)

  • FDA UDI e4517bb2-a6ec-4ac4-bb2d-e0e27adedd4b 36 fields · synced Jun 8, 2026