← Back to catalogue

Sys*Stim 208, one channel

FDA UDI

Class II (US FDA UDI)

by Mettler Electronics Corp.

Identity

Trade Name
Sys*Stim 208, one channel FDA UDI
Generic Name
Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI
Device Name
Powered muscle stimulator, one channel FDA UDI
Model / Reference
ME 208 FDA UDI
Description
Powered muscle stimulator, one channel FDA UDI

Identifiers

Catalog Number
ME 208 FDA UDI
Primary DI / UDI-DI
00816864020098 FDA UDI
510(k) Number
K031017 FDA UDI
FDA Product Code
GZJ 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

No

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 — 1.4 Pound FDA UDI

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

Sys*Stim 208, one channel 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.

Cleared under the same submission

K031017 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Mettler Electronics Corp.

Sources (1)

  • FDA UDI 7f746082-20d2-4fce-ba1e-68e0f2611a79 38 fields · synced May 30, 2026