DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)

• K Number: K202671
• Device Name: DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)
• Manufacturer: Guangzhou Xinbo Electronic Co., Ltd.
• Date Cleared: 2021-11-12 ( 424 days)
• Product Code: NUH , IRT , NGX , NYN
• Regulation Number: 882.5890
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

The DR-HO'S Back Pain Relief System Pro (Model: BPRS-1) is to be used 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 or normal household work activities by applying current to stimulate nerves. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

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

To temporarily increase local blood circulation in healthy muscles.

Heating Mode is to be used for temporary relief of minor aches and pains.

The DR-HO'S Back Pain Relief System Pro (Model: BPRS-II) is to be used 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 or normal household work activities by applying current to stimulate nerves. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

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

To temporarily increase local blood circulation in healthy muscles.

Device Description

Not Found

AI/ML Overview

This document is an FDA clearance letter for the DR-HO'S Back Pain Relief System Pro. It does not contain any information about the acceptance criteria or a study proving the device meets those criteria, as it is a device for pain relief using electrical stimulation and not an AI/imaging device.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This document primarily discusses the regulatory classification, indications for use, and general controls applicable to the device under the FDA's medical device regulations. It is not a clinical study report or a technical performance evaluation document.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).