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Biowave Percutaneous Electrodes

FDA UDI

Class II (US FDA UDI)

by BioWave Corporation

Identity

Trade Name
Biowave Percutaneous Electrodes FDA UDI
Generic Name
Analgesic PENS system probe, single-use FDA UDI
Device Name
Biowave Percutaneous Electrode Set - B FDA UDI
Model / Reference
MK78505 - BWEP01-B FDA UDI
Description
Biowave Percutaneous Electrode Set - B FDA UDI

Identifiers

Primary DI / UDI-DI
00859911006003 FDA UDI
510(k) Number
K061166 FDA UDI
FDA Product Code
NHI FDA UDI
GMDN Term
Analgesic PENS system probe, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Analgesic PENS system probe, single-use

Biowave Percutaneous Electrodes by BioWave Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic PENS system probe, single-use.

Cleared under the same submission

K061166 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BioWave Corporation

Sources (1)

  • FDA UDI 6cc12c72-1775-4a81-a5aa-aeb4c1707c5c 36 fields · synced Jun 9, 2026