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TrueStim

FDA UDI

Class II (US FDA UDI)

by Hi-Dow International Incorporated

Identity

Trade Name
TrueStim FDA UDI
Generic Name
Short-wave diathermy treatment system, home-use FDA UDI
Device Name
Pulsed Electromagnetic Field Wrap,,SHOULDER WRAP Black FDA UDI
Model / Reference
HD-08C(TSG-C1) FDA UDI
Description
Pulsed Electromagnetic Field Wrap,,SHOULDER WRAP Black FDA UDI

Identifiers

Primary DI / UDI-DI
00851640007924 FDA UDI
510(k) Number
K202337 FDA UDI
FDA Product Code
ILX FDA UDI
IRT FDA UDI
GMDN Term
Short-wave diathermy treatment system, home-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5290 FDA UDI
890.5740 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Short-wave diathermy treatment system, home-use

TrueStim by Hi-Dow International Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Short-wave diathermy treatment system, home-use.

Cleared under the same submission

K202337 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hi-Dow International Incorporated

Sources (1)

  • FDA UDI 86e4615c-4eeb-4719-aacc-a8f48aa96f35 34 fields · synced May 30, 2026