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B&L Engineering Active Surface EMG Electrode

FDA UDI

Class II (US FDA UDI)

by Pinsco, Inc.

Identity

Trade Name
B&L Engineering Active Surface EMG Electrode FDA UDI
Generic Name
Electromyographic signal amplifier FDA UDI
Device Name
Active Surface EMG Electrode Wide Spaced - Ground FDA UDI
Model / Reference
BL-AE-W/G FDA UDI
Description
Active Surface EMG Electrode Wide Spaced - Ground FDA UDI

Identifiers

Primary DI / UDI-DI
00855144007060 FDA UDI
510(k) Number
K952655 FDA UDI
FDA Product Code
IKN FDA UDI
GMDN Term
Electromyographic signal amplifier FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.1375 FDA UDI
Commercial Distribution
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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electromyographic signal amplifier

B&L Engineering Active Surface EMG Electrode by Pinsco, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromyographic signal amplifier.

Cleared under the same submission

K952655 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pinsco, Inc.

Sources (1)

  • FDA UDI de308c9a-bb62-4dd9-9d6f-cad091a2d216 35 fields · synced May 30, 2026