FDA.reportPublic FDA data

OrthoCor Medical

Primary DI
00851979007305
Brand
OrthoCor Medical
Company
Caerus Corp.
Model
Activ8 Back - Standard
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
00851979007305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851979007305008519790073058519790073050851979007305

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
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
00622356776936Shark FacialPro GlowSharkNinja Operating LLCIRT2026-10-27
00622356729444Shark™ DePuffi™SharkNinja Operating LLCIRT2026-10-26
00810050289252HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289269HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289276HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289283HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289290HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00810050289306HYPERICENORMATEC INDUSTRIES LPIRT2026-10-19
00622356753760Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
00622356753937Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
00622356759533Shark™ FacialPro Glow™SharkNinja Operating LLCIRT2026-08-17
00040337006559ThermophoreBattle Creek Equipment Co.IRT2026-08-07
088095244977693H Heating Belt3H, Co., LtdIRT2026-07-29
088095244977763H Abdomen Fomentation Device3H, Co., LtdIRT2026-07-29
088095244977833H Abdomen Fomentation Device3H, Co., LtdIRT2026-07-29
00671152103873Bug Bite Relief PenJc & A Canada Inc.IRT2026-07-16
00671152104788Bug Bite Relief PenJc & A Canada Inc.IRT2026-07-16
00840397513277Sharper ImageMerchsource, LLCIRT2026-06-30
00810140063052RenphoJoicom CorporationIRT2026-06-23
00810140063069RenphoJoicom CorporationIRT2026-06-23
08809851470145WavefacialWEERO Co., Ltd.IRT2026-06-22
00810110200562BeurerBEURER NORTH AMERICA, L.P.IRT2026-06-09
00850087490177AMOOSChangsha Yuhong Trading Co., LtdIRT2026-06-09
00850087490184AMOOSChangsha Yuhong Trading Co., LtdIRT2026-06-09
00041298995326DMID-M-S HOLDINGS, INC.IRT2026-06-05
00622356691161Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356699631Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356703048Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356704885Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356704953Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02