TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)

• K Number: K213788
• Device Name: TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
• Manufacturer: Dongguan Bohuikang Technology Co.,Ltd
• Date Cleared: 2022-05-06 ( 151 days)
• Product Code: NUH , IPF , NGX
• Regulation Number: 882.5890
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

TENS & EMS STIMULATOR has two functions and can be used for arm, shoulder, neck, back, waist, abdomen, hip, and leg.

TENS: It is used for the symptomatic relief of chronic intractable pain and the temporary relief of pain associated with sore and aching muscles in the arm, shoulder, neck, back, waist, abdomen, hip and leg due to strain from exercise or normal household and work activities.

EMS: It is used for relaxation of muscle spasm, increase of local blood flow circulation, prevention of disuse atrophy, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a TENS&EMS STIMULATOR device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of a medical device.

The letter primarily covers:

• Device Name: TENS&EMS STIMULATOR (Models: KRES-100D, KRES-1010, KRES-1020, KRES-1080)
• Regulation Number and Name: 21 CFR 882.5890, Transcutaneous Electrical Nerve Stimulator For Pain Relief
• Regulatory Class: Class II
• Product Codes: NUH, NGX, IPF
• Substantial Equivalence Determination: The FDA has determined the device is substantially equivalent to legally marketed predicate devices.
• General Controls Provisions: Mentions requirements for registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
• Indications for Use: Detailed descriptions of TENS and EMS functions for pain relief, muscle spasm relaxation, blood flow circulation, muscle re-education, etc.
• Prescription/Over-The-Counter Use: X Over-The-Counter Use.

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

A 510(k) clearance letter indicates that the FDA has reviewed the manufacturer's submission and found the device to be substantially equivalent to a predicate device. The detailed performance data and the specific studies conducted to demonstrate this equivalence (like clinical trials or performance testing against acceptance criteria) are part of the manufacturer's 510(k) submission, which is not included in this public clearance letter.

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).