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K Number
K143268
Device Name
TENS AND POWERED MUSCLE STIMULATOR
Manufacturer
SHENZHEN AS-TEC TECHNOLOGY CO., LTD
Date Cleared
2015-07-21

(250 days)

Product Code
NUH,NGX
Regulation Number
882.5890
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Transcutaneous Electrical Nerve Stimulation (TENS): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. Powered Muscle Stimulation (PMS): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Description

Not Found

AI/ML Overview

This is a K143268 510(k) premarket notification for a TENS and Powered Muscle Stimulator device. It is a clearance letter from the FDA, not a study report. Therefore, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document primarily focuses on:

  • Substantial Equivalence: The FDA has determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This means it has similar therapeutic effects and is as safe and effective as other legally marketed devices.
  • Regulatory Classification: The device is classified as Class II, under regulation 21 CFR 890.5850 for Powered Muscle Stimulator, with product codes NGX and NUH.
  • General Controls: The letter advises the manufacturer to comply with general controls provisions of the Act, including registration, listing, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
  • Indications for Use: It specifies the intended uses for the TENS function (temporary relief of pain in various body parts due to strain) and the Powered Muscle Stimulation function (to stimulate healthy muscles to improve and facilitate muscle performance).
  • Type of Use: It is intended for Over-The-Counter Use.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies because this information is not present in the provided text. The FDA clearance letter confirms regulatory approval based on demonstrating substantial equivalence to existing devices, rather than presenting a detailed performance study with acceptance criteria.

§ 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).