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K Number
K023001
Device Name
HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L
Manufacturer
HOME CARE TECHNOLOGY CO., LTD.
Date Cleared
2003-04-08

(211 days)

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

Specific Indications: Used to apply an electrical current to electrodes on patients skin to function as:

  • . Relaxation of muscle spasms.
  • Prevention or retardation of disuse atrophy. .
  • Muscle re-education. ●
  • Immediate post-surgical stimulation of calf muscles to prevent venous . thrombosis.
  • Maintaining or increasing range of motion. .

Clinical settings: The device should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

Device Description

Not Found

AI/ML Overview

The provided document describes an FDA 510(k) clearance for the Homecare HT-326L device, a powered muscle stimulator. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is primarily an approval letter confirming substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information.

§ 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).