Skinstim Product Catalog

SkinStim Model 240

High Precision Bioelectric and TENS Stimulator
Pre-Programmed for SDF1, VEGF, IGF1 and Tropoelastin Controlled Release
FDA 510K Market Cleared
Retail Price: $5,995

SkinStim Model 100

Microcurrent and LED Face Mask
FDA 510K Market Cleared
Retail Price: $350

Microcurent and LED Mini-Mask Model 200

Microcurrent Mini Face Mask
FDA 510K Market Cleared
Retail Price: $300

SkinStim EyeMask Model 100

Microcurrent Eye Mask
FDA 510K Market Cleared
Retail Price: $100

SkinStim Gel Electrodes

Microcurrent Gel Electrodes
FDA 510K Market Cleared
Retail Price: $15.00

LED Light and Bioelectric Therapy Combination Face Mask with Neck Piece Add On

Price $400 with neck add on

SkinStim GosearTM

Electroacupuncture Pen
FDA 510K Market Cleared
Retail Price: $50

SkinStim AxoBio

Room Temperature Amniotic Fluid
Produced in FDA Certified cGMP Facility in Arizona
Retail Price: $5000 per 2ml Vial

SkinStim Bedside PRF Device

Platlet Rich Fibrin Processing Device
FDA 510K Market Cleared
Retail Price: $7500

Hydrogel Skin Mask

Retail Price: $10.00

Collagen Face Mask

Retail Price: $50.00

DermaPenTM

Microneedle Array
FDA 510K Cleared
Retail Price: $3900

SkinStim Consumer Product

Notice: Product sales are subject to strict conditions including operator training certification. All marketing, labeling and use must be in full compliance with U.S. 510K authorized indications of use in the U.S.A (see below links) and CE Mark authorization outside of the USA. Any use of the product outside of these authorized indications of use MUST be via an authorized/approved IDE Investigational Device Exemption clinical study with the FDA in the USA or applicable equivalent regulatory filings and authorizations outside of the USA, with proper patient consent forms, appropriate monitoring controls and Institutional Review Board/Ethics Committee approval and oversight.

See Mettler 240 FDA 510(k) Number: (K031077) Application link below for authorized labeling and indications of use and also full listing of all 510K applications filed to date on the electrical stimulator product line manufactured for SkinStim by Mettler Electronics of Anaheim, California.

Mettler 240 FDA 510(k)

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[PDF]Mettler SYs*Stim 240, ME 240 – FDA

510(k) SUMMARY-. Mettler SYs*Stim 240, ME 240. Submitter’s Name: Mettler Electronics Corp. Address: 1333 South Claudina Street. Anaheim, CA 92805.

 
Microcurrent bioelectric Indications for Medium Frequency (Russian), Biphasic, High Volt Pulsed Current (HVPC), Interferential (4P) and Premodulated (2P3) waveforms
  • ” Relaxation of muscle spasms
  • ” Prevention or retardation of disuse atrophy
  • Increase local blood circulation
  • * Muscle re-education
  • ” Maintaining or increasing range of motion
  • ” Immediate post surgical stimulation of calf muscles to prevent venous thrombosis
Additional Indications for Microcurrent, Interferential (4P3), Premodulated (2P), Biphasic, and TENS waveforms
* Symptomatic relief and management of chronic, intractable pain
* Post-traumatic acute pain
e Post-surgical acute pain
Indications for DC (Direct Current) Mode *Relaxation of muscle spasm
The laser and cluster applicators of the Sys*Stim 240 emit infrared energy for:
  • *  Temporary increase in local blood circulation
  • *  Temporary relief of minor muscle and joint aches, pains and stiffness
  • *  Relaxation of muscles
  • *  Temporary relief of Muscle spasms
  • *  Temporary relief of minor pain and stiffness associated with arthritis

SYS*STIM 240 – 510(k) Premarket Notification

 

FDA 510(k) Applications Submitted by METTLER ELECTRONICS …

510k.medevnet.com/…/index.cfm?…METTLER%20ELECTRONICS%20CORP%2E

 

K111482 · 05/27/2011 · SONICATOR PLUS 920 · METTLER ELECTRONICS CORP. K113017 · 12/05/2011 · SYS*STIM 240 · METTLER ELECTRONICS CORP.

 
 

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