FDA.reportPublic FDA data

ActiPatch

Primary DI
00851329005159
Brand
ActiPatch
Company
BioElectronics Corporation
Model
088
Catalog number
090-4
Device description
Back Pain Advanced Long-Lasting Relief
Published
2020-07-23
Public version status
Update
Distribution status
Not 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
00851329005159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851329005159008513290051598513290051590851329005159

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.

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
301-874-4890brice@bielcorp.com
301-874-4890rcarusone@bielcorp.com
301-874-4890skoneru@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
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
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
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
00851329005203ActiPatchBioElectronics CorporationPQY2020-07-23
00851329005340ActiPatchBioElectronics CorporationPQY2020-07-23