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K Number
K210269
Device Name
PowerDot PD-01MT2 Muscle Stimulator
Manufacturer
Smartmissimo Technologies Pte Ltd
Date Cleared
2021-02-23

(22 days)

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

The PowerDot PD-01MT2 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-01MT2 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

This document is a 510(k) clearance letter from the FDA for a muscle stimulator device, the PowerDot PD-01MT2. It does not contain information about acceptance criteria or specific study data proving the device meets those criteria.

The letter grants clearance based on a review, implying that the manufacturer provided sufficient data in their 510(k) submission to demonstrate substantial equivalence to a legally marketed predicate device. However, the details of that submission, including acceptance criteria, performance data, sample sizes, ground truth establishment, or expert qualifications, are not included in this public letter.

Therefore, I cannot provide the requested information based solely on the provided text. The document acts as an approval notice, not a detailed technical report of the studies performed.

§ 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).