FDA.reportPublic FDA data

ActiPatch

Primary DI
00851329005487
Brand
ActiPatch
Company
BioElectronics Corporation
Model
088
Catalog number
103-4
Device description
ActiPatch Knee Pain Relief Therapy 100 pack
Published
2021-06-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851329005487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851329005487008513290054878513290054870851329005487

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held deep-tissue electromagnetic stimulatorA battery-powered, hand-held device designed to apply an electromagnetic (EM) field to body deep tissues to help reduce pain associated with musculoskeletal/neurological disorders (e.g., arthritis, sciatica) and/or to treat soft-tissue wounds and injuries with no production of a therapeutic deep heat. It is a self-contained electronic unit with controls intended to be applied to the body to emit short-time pulsed, radio-frequency energy [pulsed electromagnetic fields (PEMF)] to tissues at a level below the patient's heat sensory perception threshold. It is not intended to apply an electric current directly to the body. The device is intended to be used in clinical and home settings.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3018744890skoneru@bielcorp.com
3018744890rcarusone@bielcorp.com
3018744890brice@bielcorp.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851329005258ActiPatch088098-42021-06-09
00851329005241ActiPatch 088103-42021-06-09
00851329005470ActiPatch 088090-42021-06-09
00851329005494ActiPatch 088098-42021-06-09
80851329005155ActiPatch 088090-42021-06-09
00851329005128RecoveryRx 088214-42021-03-03
00851329005012ActiPatch088103-42020-07-23
00851329005159ActiPatch088090-42020-07-23
00851329005203ActiPatch0771682020-07-23
00851329005340ActiPatch088720-42020-07-23
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
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
00851329005203ActiPatchBioElectronics CorporationPQY2020-07-23
00851329005340ActiPatchBioElectronics CorporationPQY2020-07-23