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Sys*Stim 228

FDA UDI

Class II (US FDA UDI)

by Mettler Electronics Corp.

Identity

Trade Name
Sys*Stim 228 FDA UDI
Generic Name
Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI
Device Name
Neuromuscular stimulator features 4 discrete waveforms (advanced 2-channel, multifunction) FDA UDI
Model / Reference
ME 228 FDA UDI
Description
Neuromuscular stimulator features 4 discrete waveforms (advanced 2-channel, multifunction) FDA UDI

Identifiers

Catalog Number
ME 228 FDA UDI
Primary DI / UDI-DI
00816864020159 FDA UDI
510(k) Number
K964028 FDA UDI
FDA Product Code
LIH FDA UDI
IPF FDA UDI
GMDN Term
Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
890.5850 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

Yes

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Weight — 4.9 Pound FDA UDI

Category: Physical therapy transcutaneous electrical stimulation system, line-powered

Sys*Stim 228 by Mettler Electronics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Physical therapy transcutaneous electrical stimulation system, line-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mettler Electronics Corp.

Sources (1)

  • FDA UDI e4762904-44a1-4edd-8385-d74fd6599767 38 fields · synced May 30, 2026