Identity

Trade Name
SOQI FDA UDI
Generic Name
External electric-heating core temperature regulation system pad FDA UDI
Model / Reference
HM-518 FDA UDI

Identifiers

Primary DI / UDI-DI
06931294730011 FDA UDI
FDA Product Code
IRQ FDA UDI
GMDN Term
External electric-heating core temperature regulation system pad FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5950 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: External electric-heating core temperature regulation system pad

Soqi by HSIN TEN HEALTH & WEALTH INDUSTRY(HEFEI)Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External electric-heating core temperature regulation system pad.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI f4710517-93a1-4164-8483-cb53a3629996 32 fields · synced May 30, 2026