FDA.reportPublic FDA data

OrthoCor Medical

Primary DI
00851979007442
Brand
OrthoCor Medical
Company
Caerus Corp.
Model
Activ8 Back - XS
Device description
The Activ8 family of devices are portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (PEMF) stimulation therapy and electronic heat for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.
Published
2025-03-10
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
IRTPad, Heating, Powered

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241395000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241395000Active System; Avenue8Caerus Corporation2024-12-18ILX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851979007442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851979007442008519790074428519790074420851979007442

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
Combination product
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851979007282OrthoCor MedicalPemf NOW2025-08-11
00851979007657OrthoCor MedicalONE2025-08-11
00851979007305OrthoCor MedicalActiv8 Back - Standard2025-03-10
00851979007312OrthoCor MedicalActiv8 Knee - XS2025-03-10
00851979007435OrthoCor MedicalActiv8 Knee - XL2025-03-10
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

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