FDA.reportPublic FDA data

ActiPatch

Primary DI
00851329005203
Brand
ActiPatch
Company
BioElectronics Corporation
Model
077
Catalog number
168
Device description
Back , Knee, Muscle and Joint 7 day trial
Published
2020-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PQYNonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQYNonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of PainPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152432000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152432000ActiPatch(R)Bioelectronics Corporation2017-02-03PQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851329005203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851329005203008513290052038513290052030851329005203

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter15Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
301-874-4890skoneru@bielcorp.com
301-874-4890rcarusone@bielcorp.com
301-874-4890brice@bielcorp.com

Regulatory Flags#

DUNS number
101591571
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851329005340ActiPatch088720-42020-07-23
00851329005258ActiPatch088098-42021-06-09
00851329005241ActiPatch 088103-42021-06-09
00851329005470ActiPatch 088090-42021-06-09
00851329005487ActiPatch 088103-42021-06-09
00851329005494ActiPatch 088098-42021-06-09
80851329005155ActiPatch 088090-42021-06-09
00851329005128RecoveryRx 088214-42021-03-03
00851329005012ActiPatch088103-42020-07-23
00851329005159ActiPatch088090-42020-07-23
00851329005050ActiPatch 088090-42015-07-22
00851329005463KT RECOVERY+ WAVE088100-KT2021-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851329005241ActiPatch BioElectronics CorporationPQY2021-06-09
00851329005258ActiPatchBioElectronics CorporationPQY2021-06-09
00851329005470ActiPatch BioElectronics CorporationPQY2021-06-09
00851329005487ActiPatch BioElectronics CorporationPQY2021-06-09
00851329005494ActiPatch BioElectronics CorporationPQY2021-06-09
80851329005155ActiPatch BioElectronics CorporationPQY2021-06-09
00851329005128RecoveryRxBioElectronics CorporationPQY2021-03-03
00851329005463KT RECOVERY+ WAVEBioElectronics CorporationPQY2021-03-03
00851329005012ActiPatchBioElectronics CorporationPQY2020-07-23
00851329005159ActiPatchBioElectronics CorporationPQY2020-07-23
00851329005340ActiPatchBioElectronics CorporationPQY2020-07-23