Pain Therapy Device(Model: P.T.S-X)

• K Number: K230711
• Device Name: Pain Therapy Device(Model: P.T.S-X)
• Manufacturer: Guangzhou Xinbo Electronic Co., Ltd.
• Date Cleared: 2024-05-16 ( 428 days)
• Product Code: NGX , GZJ , IPF , NUH , NYN
• Regulation Number: 890.5850
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

The Pain Therapy Device (Model: P.T.S-X):

TENS (Transcutaneous electrical nerve stimulation):

• 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 (Electrical muscle stimulation):
• To stimulate healthy muscles in order to improve and facilitate muscle performance.
• To temporarily increase local blood circulation in healthy muscles.

NMES (Neuromuscular electrical stimulation):

• 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. NEMS 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 is an FDA 510(k) clearance letter and an Indications for Use statement for a medical device called "Pain Therapy Device (Model: P.T.S-X)".

This document specifies the regulatory classification of the device, its product codes, and the conditions for its use (TENS, EMS, NMES). However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

Regulation Number and Section

§ 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).