FDA.reportPublic FDA data

RecoveryRx

Primary DI
00851329005128
Brand
RecoveryRx
Company
BioElectronics Corporation
Model
088
Catalog number
214-4
Device description
RecoveryRx Postoperative Pain Therapy Kit 720 hours
Published
2021-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
PQYNonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep HeatPhysical Medicine2
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
00851329005128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851329005128008513290051288513290051280851329005128

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
3018744890brice@bielcorp.com
3018744890rcarusone@bielcorp.com
3018744890zatiq@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
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
00851979007282OrthoCor MedicalCaerus Corp.ILX2025-08-11
00851979007657OrthoCor MedicalCaerus Corp.ILX2025-08-11
00851979007305OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007312OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007435OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007442OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007503OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007510OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007527OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007534OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007558OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007565OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007572OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007596OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007619OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007015OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007022OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007039OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007046OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007336OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007367OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007381OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007404OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007428OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007466OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007480OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007664OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007671OrthoCor MedicalCaerus Corp.ILX2025-03-03
00081009308007TrueStimHi-Dow International IncorporatedILX2023-09-28
00851329005241ActiPatch BioElectronics CorporationPQY2021-06-09