ActiPatch 090-4

GUDID 00851329005159

Back Pain Advanced Long-Lasting Relief

Bioelectronics Corporation

Hand-held deep-tissue electromagnetic stimulator
Primary Device ID00851329005159
NIH Device Record Key15bebe16-bf68-4bbc-8f70-8e2c76886da8
Commercial Distribution Discontinuation2025-07-23
Commercial Distribution StatusIn Commercial Distribution
Brand NameActiPatch
Version Model Number088
Catalog Number090-4
Company DUNS101591571
Company NameBioelectronics 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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com
Phone301-874-4890
Emailbrice@bielcorp.com

Device Dimensions

Outer Diameter15 Inch
Outer Diameter15 Inch
Outer Diameter15 Inch
Outer Diameter15 Inch
Outer Diameter15 Inch
Outer Diameter15 Inch
Outer Diameter15 Inch
Outer Diameter15 Inch
Outer Diameter15 Inch
Outer Diameter15 Inch
Outer Diameter15 Inch
Outer Diameter15 Inch
Outer Diameter15 Inch
Outer Diameter15 Inch

Operating and Storage Conditions

Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100851329005159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PQYNonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

On-Brand Devices [ActiPatch]

00851329005050Back Pain Advanced long -Lasting Relief
00851329005340Back, Knee, Muscle & Joint Advanced Long-Lasting Relief.
00851329005203Back , Knee, Muscle and Joint 7 day trial
00851329005159Back Pain Advanced Long-Lasting Relief
00851329005012Knee Pain Advanced Long-Lasting Relief
80851329005155ActiPatch Back Pain Therapy Kit 5 pack
00851329005494ActiPatch Muscle and Joint Relief Therapy 100 pack
00851329005487ActiPatch Knee Pain Relief Therapy 100 pack
00851329005470ActiPatch Back Pain Relief Therapy 100 pack
00851329005258ActiPatch Muscle and Joint Pain Therapy Kit 5 pack
00851329005241ActiPatch Knee Pain Therapy Device 5 pack

Trademark Results [ActiPatch]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACTIPATCH
ACTIPATCH
77922562 3899022 Live/Registered
BioElectronics Corporation
2010-01-28

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