BiowaveHOME

GUDID 00859911006072

BiowaveHOME Neurostimulator

BIOWAVE CORPORATION

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID00859911006072
NIH Device Record Key02beb21f-04dc-4228-ba7f-a1ea8ca93b94
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiowaveHOME
Version Model NumberBWHD01
Company DUNS005759084
Company NameBIOWAVE CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com
Phone1-877-246-9283
Emailinfo@biowave.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100859911006072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-23
Device Publish Date2016-08-01

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00859911006256 - BioWave Silver Foot-Ankle BioWrap S/M2023-08-15 BioWrap Wearable Compression Electrode Garment that utilizes advanced permanent silver fabric electrodes that work exclusively w
00859911006461 - BioWave Silver Back BioWrap L/XL2023-08-15 BioWrap Wearable Compression Electrode Garment that utilizes advanced permanent silver fabric electrodes that work exclusively w
00859911006492 - BioWave Silver Foot-Ankle BioWrap L/XL2023-08-15 BioWrap Wearable Compression Electrode Garment that utilizes advanced permanent silver fabric electrodes that work exclusively w
00859911006508 - BioWave Silver Knee BioWrap L/XL2023-08-15 BioWrap Wearable Compression Electrode Garment that utilizes advanced permanent silver fabric electrodes that work exclusively w
00859911006546 - BioWave Silver Thigh-Calf BioWrap S/M2023-08-15 BioWrap Wearable Compression Electrode Garment that utilizes advanced permanent silver fabric electrodes that work exclusively w

Trademark Results [BiowaveHOME]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOWAVEHOME
BIOWAVEHOME
85664963 4932692 Live/Registered
Biowave Corporation
2012-06-29

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