MAUDE Adverse Event Report: APR CO., LTD MEDICUBE AGE-R BOOSTER PRO; STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES

Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Nerve Damage (1979); Undesired Nerve Stimulation (1980); Pain (1994); Sleep Dysfunction (2517); Skin Inflammation/ Irritation (4545)
Date of Event	07/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As a concerned consumer and avid user of beauty devices, i am writing to report potential violations of fda regulations by medicube (operated by apr us inc; address: business center, suite 200, irvine, california, 92618, united states of america; email:medicube_uscs@apr-in.Com).The company is unlawfully marketing its products as medical devices without proper fda registration, which misleads consumers and poses health risks.1.Unregistered medical device claims medicube promotes the product named booster pro on its official website (https://medicube.Us/products/age-r-booster-pro) and amazon pages (https://www.Amazon.Com/medicube-booster-beauty-massager- looking/dp/b0cwk6yq7v), advertising medical benefits such as: enhanced absorption, enhanced radiance, elasticity care, facial contouring, pore care, microcurrent.These claims imply the product is intended to treat or modify physiological functions, classifying it as class ii medical devices under fda guidelines.However, a search of the fda device registration database shows no record of medicube products being registered as class ii devices.This violates fd&c act § 510(k), which requires premarket notification for class ii devices before claiming medical uses.2.Personal experience and safety concerns as a consumer, i experienced severe adverse reactions after using this device according to all provided instructions.Within hours of my first use, i developed intense facial nerve pain, persistent skin irritation, and inflammatory breakouts that required medical attention.My experience aligns with many other customers reporting identical severe reactions: permanent acne scarring, nerve damage requiring neurologist consultation, rosacea activation, and systemic effects including sleep disruption and muscle pain.This product is causing medical-grade adverse effects, yet lacks proper fda medical device registration.3.Request for action - enforce 510(k) registration: remove "medicube" from the market until 510(k) clearance and establishment registration are confirmed.- issue warning letters: cite violations of fd&c act, 21 cfr labeling rules, and ftc act.- public warning: alert consumers via fda's medwatch.

• Brand Name: MEDICUBE AGE-R BOOSTER PRO
• Common Device Name: STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES
• Manufacturer (Section D): APR CO., LTD; 300 olympic-ro, songpa-gu; seoul 05551 ; KS 05551
• MDR Report Key: 22771830
• Report Number: MW5174314
• Device Sequence Number: 14587489
• Product Code: NFO
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Disability
• Patient Sex: Unknown