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BiowaveHOME

FDA UDI

Class II (US FDA UDI)

by BioWave Corporation

Identity

Trade Name
BiowaveHOME FDA UDI
Generic Name
Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Device Name
BiowaveHOME Neurostimulator FDA UDI
Model / Reference
BWHD01 FDA UDI
Description
BiowaveHOME Neurostimulator FDA UDI

Identifiers

Primary DI / UDI-DI
00859911006072 FDA UDI
510(k) Number
K152437 FDA UDI
FDA Product Code
GZJ FDA UDI
GMDN Term
Physical therapy transcutaneous neuromuscular electrical stimulation system 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

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

Category: Physical therapy transcutaneous neuromuscular electrical stimulation systemAnalgesic transcutaneous electrical nerve stimulation system

BiowaveHOME by BioWave Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BioWave Corporation

Sources (1)

  • FDA UDI 02beb21f-04dc-4228-ba7f-a1ea8ca93b94 36 fields · synced Jun 9, 2026