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Clearances

FDA Clearances

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Class I Indications:

The OW100S (model OW100S-US) is intended for:

  • Relief of minor muscle aches and pains

  • Temporary increase in local blood circulation

  • Activation of connective tissue

Class II Indications:

  • The OW100S (OW100S-US) is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OW100S OW100S-US is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.
  • The OW100S (OW100S-US) is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years or older). The OW100S OW100S-US is indicated for use in conjunction with standard of care burn care treatments.

Activation relief pain
  • Relief of minor muscle aches and pains
  • Temporary increase in local blood circulation
  • Activation of connective tissue
Orthogold clearances

Burns

Diabetic Ulcers clearance

Diabetic Foot Ulcers

Connective tissue clearances

Activation of Connective Tissue

Health Canada License

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Indications for Use:

  • Tendionopathies; Tendinosis and Tendonitis
    • Shoulder Impingement Syndrome / Rotator Cuff (Calcifying) Tendinitis, Elbow Epicondylitis Humeri Radialis / Ulnaris, Gluteal / Trochanateric Tendinopathy, Quadriceps / Hamstring Tendinopathy, Patellar Tendinopathy, Achillodynia
  • Plantar Faciitis / Heel Spur
  • Stress Fractures
  • Acute Wounds and Burns
  • Chronic Wounds and Ulcers
  • Pathologic Scarring
  • Erectile Dysfunction
  • Chronic Pelvic Pain / Chronic Prostatitis
Screenshot

Medical device license renewal