FDA.reportPublic FDA data

OrthoCor Medical

Primary DI
00851979007657
Brand
OrthoCor Medical
Company
Caerus Corp.
Model
ONE
Device description
OrthoCor ONE is a lightweight, portable, portable pulsed electromagnetic field (Nonthermal Shortwave Diathermy) device designed for adjunctive use in the palliative treatment of post-operative pain and edema.
Published
2025-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851979007657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851979007657008519790076578519790076570851979007657

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

Regulatory Flags#

DUNS number
021776723
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851979007282OrthoCor MedicalPemf NOW2025-08-11
00851979007305OrthoCor MedicalActiv8 Back - Standard2025-03-10
00851979007312OrthoCor MedicalActiv8 Knee - XS2025-03-10
00851979007435OrthoCor MedicalActiv8 Knee - XL2025-03-10
00851979007442OrthoCor MedicalActiv8 Back - XS2025-03-10
00851979007503OrthoCor MedicalActiv8 Back - XL2025-03-10
00851979007510OrthoCor MedicalActiv8 Ankle2025-03-10
00851979007527OrthoCor MedicalActiv8 Knee - Standard2025-03-10
00851979007534OrthoCor MedicalActiv8 Wrist2025-03-10
00851979007558OrthoCor MedicalActiv8 Neck2025-03-10
00851979007565OrthoCor MedicalActiv8 Shoulder2025-03-10
00851979007572OrthoCor MedicalActiv8 Elbow2025-03-10
00851979007596OrthoCor MedicalActiv8 Universal2025-03-10
00851979007619OrthoCor MedicalActiv8 Foot2025-03-10
00851979007015OrthoCor MedicalActive System Knee - XS2025-03-03
00851979007022OrthoCor MedicalActive System Knee - XL2025-03-03
00851979007039OrthoCor MedicalActive System Back - XS2025-03-03
00851979007046OrthoCor MedicalActive System Back - XL2025-03-03
00851979007336OrthoCor MedicalActive System Ankle2025-03-03
00851979007367OrthoCor MedicalActive System Wrist2025-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851979007282OrthoCor 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
00851329005128RecoveryRxBioElectronics CorporationILX2021-03-03
00868924000021Provant InfinityRegenesis Biomedical, Inc.ILX2021-01-21