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K Number
K231789
Device Name
Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)
Manufacturer
Guangzhou Xinbo Electronic Co., Ltd.
Date Cleared
2024-03-11

(265 days)

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

The Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII):

TENS

  • For temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise, work or normal household work activities by applying transcutaneous electrical current to stimulate the nerves.

  • For relief of pain associated with arthritis.

  • For symptomatic relief and management of chronic intractable pain

EMS:

  • To stimulate healthy muscles in order to improve and facilitate muscle performance.

  • To temporarily increase local blood circulation in healthy muscles.

NMES:

  • For relaxation of muscle spasm.

  • Increase of blood flow circulation.

  • Prevention or retardation of disuse muscle atrophy.

  • Muscle re-education.

  • Maintaining or increasing range of motion.

  • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

  • For Users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankle/feet, NMES through the foot electrodes is intended to use as an adjunctive treatment (as an additional treatment to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria for a device, nor does it describe a study proving a device meets such criteria. The document is an FDA 510(k) clearance letter for a "Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)", indicating that the device has been found substantially equivalent to legally marketed predicate devices.

The letter details:

  • The device name and manufacturer.
  • The FDA regulation number, name, and product codes.
  • General controls provisions and additional requirements for the device.
  • Contact information for FDA.
  • The Indications for Use of the device, which include TENS, EMS, and NMES functions.

It does not include any technical specifications, performance metrics, clinical study results, or details on how substantial equivalence was demonstrated beyond the general statement of clearance. Therefore, I cannot generate the requested table or describe a study proving the device meets acceptance criteria based on this input.

§ 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).