OrthoCor Medical Activ8 Back - StandardRecalls & reported problems

Caerus Corp. · 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. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851979007305), received between Sep 5, 2025 and Sep 5, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Charge” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Charge1
Overheating of Device1

Patient problems

Skin Burning Sensation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 5, 2025Failure to Charge; Overheating of Device; Failure to Charge; Overheating of Device
USER'S FIRST BATTERY WOULD NOT STAY CHARGED; WE SENT OUT A NEW BATTERY PACK AND IT GOT HOT WHILE CHARGING. WE ARE SENDING OUT A NEW DEVICE TO HIM WITH AN EXTRA BATTERY PACK. SPOKE TO PATIENT TO MAKE SURE HE RECEIVED THE NEW DEVICE, HE LET ME KNOW THAT IT WAS HOT TO THE TOUCH AND FELT LIKE IT BURNED HIM, BUT HE HAS NO LINGERING REDNESS OR BLISTERING AND DID NOT NEED TO SEEK MEDICAL ATTENTION.
Patient problems: Skin Burning Sensation
MAUDE report 22979727 ↗

Device details

UDI-DI	`00851979007305`
Brand	OrthoCor Medical
Model	Activ8 Back - Standard
Company	Caerus Corp.
Product code	ILX · Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Class	Class 2
FDA submission	K241395
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Mar 18, 2025

Device type (GMDN): Hand-held deep-tissue electromagnetic stimulator

A 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.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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