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K Number
K181759
Device Name
PowerDot PD-01MT
Manufacturer
Smartmissimo Technologies Pte Ltd
Date Cleared
2018-11-09

(130 days)

Product Code
IPF,GZJ,NGX,NUH
Regulation Number
890.5850
Type
Abbreviated
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

PowerDot PD-01MT stimulator is a prescription device which is intended to be used following the directions of a healthcare provider. The device can be either used by the therapist in healthcare facility setting (when operated from PowerDot Doctor Mobile Application) or by patient/lay operator in a home environment (when operated from PowerDot Patient Mobile Application).

PowerDot PD-01MT has the following indications for use:

NMES

  • Retarding or preventing disuse atrophy
  • Maintaining or increasing range of motion
  • Re-educating muscles
  • Relaxation of muscle spasms
  • Increasing local blood circulation
  • Prevention of venous thrombosis of the calf muscles immediately after surgery
  • Stimulation of healthy muscles in order to improve or facilitate muscle performance

TENS

  • Symptomatic relief and management of chronic, intractable pain

  • Post-surgical and post-trauma acute pain

  • Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "PowerDot PD-01MT," which is a powered muscle stimulator.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and lists its indications for use (NMES and TENS). However, it does not describe any specific performance acceptance criteria for the device, nor does it detail any study conducted to demonstrate the device's performance against such criteria.

Therefore, I cannot provide the requested information based on the input text.

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).