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truTENStronic

FDA UDI

Class II (US FDA UDI)

by Hong Qiangxing (Shenzhen) Electronics Limited

Identity

Trade Name
truTENStronic FDA UDI
Generic Name
Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Model / Reference
TENS FDA UDI

Identifiers

Primary DI / UDI-DI
10002018010803 FDA UDI
510(k) Number
K121719 FDA UDI
FDA Product Code
GZJ FDA UDI
GMDN Term
Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

truTENStronic by Hong Qiangxing (Shenzhen) Electronics Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K121719 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hong Qiangxing (Shenzhen) Electronics Limited

Sources (1)

  • FDA UDI ca131282-101f-4be6-8959-8d7e835ad9ce 34 fields · synced Jun 1, 2026