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K Number
K050174
Device Name
BIO-STIM KIT
Manufacturer
SKYLARK DEVICE & SYSTEMS CO., LTD
Date Cleared
2005-09-07

(225 days)

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

This BIO-STIM KIT is intended for temporary relief of pain associated with sore and aching muscle in the lower back due to strain from exercise or normal household and work activities.

Device Description

Not Found

AI/ML Overview

This is a scanned FDA 510(k) clearance letter for the "BIO-STM KIT", a transcutaneous electrical nerve stimulator for pain relief. The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed. It does not include performance data or studies.

Therefore, I cannot provide the requested information.

§ 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).