P-STIM

• K Number: K140788
• Device Name: P-STIM
• Manufacturer: BIEGLER GMBH
• Date Cleared: 2014-06-27 ( 88 days)
• Product Code: BWK
• Regulation Number: N/A
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

P-Stim is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Device Description

P-Stim is an electro-acupuncture device

AI/ML Overview

I am sorry, but the provided document does not contain information on acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the P-Stim System, an electro-acupuncture device. It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations.

The document includes:

• The device name: P-Stim System
• Regulation Name: Electro-Acupuncture Stimulator
• Regulatory Class: Unclassified
• Product Code: BWK
• Indications for Use: "P-Stim is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states."
• Type of Use: Prescription Use

However, there is no mention of specific acceptance criteria (e.g., performance metrics, thresholds) or any study details such as sample sizes, ground truth establishment, expert qualifications, or adjudication methods for demonstrating performance against such criteria. The letter confirms clearance based on substantial equivalence, not on the presentation of a performance study with detailed acceptance criteria.

Regulation Number and Section

N/A