FDA.reportPublic FDA data

ActiPatch

Primary DI
00851329005258
Brand
ActiPatch
Company
BioElectronics Corporation
Model
088
Catalog number
098-4
Device description
ActiPatch Muscle and Joint Pain Therapy Kit 5 pack
Published
2021-06-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
00851329005258PrimaryGS10
00851329005081Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851329005258008513290052588513290052580851329005258
00851329005081008513290050818513290050810851329005081

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.

Contacts#

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

Regulatory Flags#

DUNS number
101591571
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
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
00851329005203ActiPatchBioElectronics CorporationPQY2020-07-23
00851329005340ActiPatchBioElectronics CorporationPQY2020-07-23