BioWaveGO RX

GUDID 00859911006430

BioWaveGO wearable portable neurostimulator for prescription use

BIOWAVE CORPORATION

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID00859911006430
NIH Device Record Key53e4a23a-8bdb-422e-8e46-93db880ecd63
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioWaveGO RX
Version Model NumberBWG-RX
Company DUNS005759084
Company NameBIOWAVE CORPORATION
Device Count1
DM Exempttrue
Pre-market Exempttrue
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
Emailsupport@biowave.com
Phone1-877-246-9283
Emailsupport@biowave.com
Phone1-877-246-9283
Emailsupport@biowave.com
Phone1-877-246-9283
Emailsupport@biowave.com
Phone1-877-246-9283
Emailsupport@biowave.com
Phone1-877-246-9283
Emailsupport@biowave.com
Phone1-877-246-9283
Emailsupport@biowave.com
Phone1-877-246-9283
Emailsupport@biowave.com
Phone1-877-246-9283
Emailsupport@biowave.com
Phone1-877-246-9283
Emailsupport@biowave.com
Phone1-877-246-9283
Emailsupport@biowave.com
Phone1-877-246-9283
Emailsupport@biowave.com
Phone1-877-246-9283
Emailsupport@biowave.com
Phone1-877-246-9283
Emailsupport@biowave.com
Phone1-877-246-9283
Emailsupport@biowave.com
Phone1-877-246-9283
Emailsupport@biowave.com
Phone1-877-246-9283
Emailsupport@biowave.com

Device Dimensions

Length4 Inch
Width3 Inch
Depth1 Inch
Length4 Inch
Width3 Inch
Depth1 Inch
Length4 Inch
Width3 Inch
Depth1 Inch
Length4 Inch
Width3 Inch
Depth1 Inch
Length4 Inch
Width3 Inch
Depth1 Inch
Length4 Inch
Width3 Inch
Depth1 Inch
Length4 Inch
Width3 Inch
Depth1 Inch
Length4 Inch
Width3 Inch
Depth1 Inch
Length4 Inch
Width3 Inch
Depth1 Inch
Length4 Inch
Width3 Inch
Depth1 Inch
Length4 Inch
Width3 Inch
Depth1 Inch
Length4 Inch
Width3 Inch
Depth1 Inch
Length4 Inch
Width3 Inch
Depth1 Inch
Length4 Inch
Width3 Inch
Depth1 Inch
Length4 Inch
Width3 Inch
Depth1 Inch
Length4 Inch
Width3 Inch
Depth1 Inch
Length4 Inch
Width3 Inch
Depth1 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100859911006430 [Primary]

FDA Product Code

GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-23
Device Publish Date2023-06-15

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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

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