GMR&D Medical Device Manufacturing
KFDA Approved Indications

Approved Indications

Treating Various Pain Conditions with 6 Therapy Modalities

Painfree8800 is a Class 3 medical device approved by KFDA for 6 modalities, capable of treating various acute and chronic pain conditions.

6

Therapy Modalities

50+

Conditions

Class 3

Device Class

Treatable Pain Types

Various pain types that can be effectively managed with Painfree8800

01

Chronic Pain

Persistent pain conditions lasting more than 3 months

  • --Chronic back pain
  • --Fibromyalgia
  • --Complex Regional Pain Syndrome (CRPS)
02

Neuropathic Pain

Pain caused by nerve damage or dysfunction

  • --Diabetic neuropathy
  • --Trigeminal neuralgia
  • --Post-herpetic neuralgia
03

Musculoskeletal Pain

Pain affecting muscles, bones, joints, and ligaments

  • --Arthritis
  • --Tendinitis
  • --Muscle stiffness
04

Post-Operative Pain

Acute and chronic pain occurring after surgery

  • --Post-spinal surgery pain
  • --Post-joint surgery pain
  • --Post-surgical neuropathy
05

Cancer Pain

Pain related to cancer or cancer treatment

  • --Tumor-related pain
  • --Chemotherapy-induced peripheral neuropathy (CIPN)
  • --Post-radiation pain
06

Inflammatory Pain

Pain caused by tissue inflammation

  • --Rheumatoid arthritis
  • --Synovitis
  • --Bursitis

Indications by Therapy Modality

Discover the conditions each therapy technology is most effective for

PSC Therapy

A16010.03

Electrical stimulation therapy that reorganizes pain signals by stimulating A-delta and C fibers

Chronic PainNeuropathic PainCancer PainPost-Surgical PainShingles PainCIPNCRPSFibromyalgia
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Laser Therapy (LLLT)

A37020.01

Cell activation and tissue healing promotion using low-level laser

Pain ReliefImproved CirculationInflammation ReductionWound HealingMuscle RecoveryJoint Pain
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Quantum Therapy

A16010.01

Bio-resonance therapy utilizing 3,800+ bio-frequencies

Cellular ActivationImmune EnhancementChronic FatigueStress ReliefMetabolic ImprovementHolistic Healing
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Ultrasound Therapy

A16090.01

Deep tissue therapy using 1.2-1.4MHz ultrasound

Deep Tissue PainTendonitisBursitisScar TissueMuscle SpasmArthritis
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PEMF Therapy

A85020.01

Cell regeneration and circulation improvement using pulsed electromagnetic fields

Improved CirculationCell RegenerationBone HealingEdema ReductionNerve PainInflammation Reduction
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Thermal Therapy

A16150.01

Deep heat therapy using far-infrared radiation

Muscle RelaxationCirculation BoostChronic Pain ReliefStiffness ReliefBack PainArthritic Pain
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Regulatory Approval

KFDA Approved Medical Device

Painfree8800 has received Class 3 medical device approval from the Korean Food and Drug Administration (KFDA) for 6 modalities, with National Health Insurance coverage available.

6

Approved Modalities

Class 3

Device Class

NHI

Insurance Coverage

Find the Right Treatment for Your Patients

Learn more about Painfree8800's various indications and get expert consultation.

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