ActiPatch 720-4

GUDID 00851329005340

Back, Knee, Muscle & Joint Advanced Long-Lasting Relief.

Bioelectronics Corporation

Hand-held deep-tissue electromagnetic stimulator Hand-held deep-tissue electromagnetic stimulator Hand-held deep-tissue electromagnetic stimulator Hand-held deep-tissue electromagnetic stimulator Hand-held deep-tissue electromagnetic stimulator Hand-held deep-tissue electromagnetic stimulator Hand-held deep-tissue electromagnetic stimulator Hand-held deep-tissue electromagnetic stimulator Hand-held deep-tissue electromagnetic stimulator Hand-held deep-tissue electromagnetic stimulator Hand-held deep-tissue electromagnetic stimulator Hand-held deep-tissue electromagnetic stimulator Hand-held deep-tissue electromagnetic stimulator Hand-held deep-tissue electromagnetic stimulator
Primary Device ID00851329005340
NIH Device Record Key0e8d8ad6-ed54-4649-9768-3d7b9ac17b72
Commercial Distribution Discontinuation2025-07-23
Commercial Distribution StatusIn Commercial Distribution
Brand NameActiPatch
Version Model Number088
Catalog Number720-4
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

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
GS100851329005340 [Primary]
GS100851329005340 [Primary]
GS100851329005340 [Primary]
GS100851329005340 [Primary]
GS100851329005340 [Primary]
GS100851329005340 [Primary]
GS100851329005340 [Primary]
GS100851329005340 [Primary]
GS100851329005340 [Primary]
GS100851329005340 [Primary]
GS100851329005340 [Primary]
GS100851329005340 [Primary]
GS100851329005340 [Primary]
GS100851329005340 [Primary]

FDA Product Code

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

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