Search Results

Body Contouring Machine can be used to:

• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
• Strengthening, Toning and Firming of buttocks, thighs and calves.
• Improvement of muscle tone and firmness, for strengthening muscles in arms.

Body Contouring Machine is a non-invasive treatment device. The device generates an electromagnetic field that interacts with human tissue. Body Contouring Machine is equipped with four handles, two each for ZH-01 and ZH-03, which can treat different parts of the same time. The device is equipped with a 15.6-inch true-color touch screen and provides two operating modes, intelligent and professional, to meet the different needs of users.
The Body Contouring Machine includes seven models in this submission, CS2,CS3,CS5,CS7, CS8,CS11, and CS13, all seven models have same principle, software, operation etc., only differences are appearance.

The provided FDA 510(k) summary (K232181) for the "Body Contouring Machine" (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) does not include specific acceptance criteria or a study proving that the device meets such criteria in terms of clinical effectiveness. This omission is explicitly stated with "No clinical study is included in this submission."

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (BTL 799-2L, K190456) through non-clinical testing and comparison of technical specifications and indications for use.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative clinical performance acceptance criteria (e.g., minimum percentage improvement in muscle tone, specific reduction in abdominal circumference). The "performance" demonstrated is primarily through compliance with electrical safety, EMC, and other non-clinical standards, and by showing that its technical specifications are comparable to the predicate device.

• IEC 60601-1:2012
• IEC 60601-1-2:2014+A1:2020
• IEC 60601-2-10:2012/AMD2:2023
• IEC 62304:2015
• ISO 14971:2019
• ISO 10993-1:2018
• ISO 10993-5:2009
• ISO 10993-10:2010
• Magnetic density test results supported substantial equivalence. |
  | Technical Equivalence to Predicate | Parameters, principles of action, safety features, and indications for use should be substantially equivalent to the predicate device. | Demonstrated Substantial Equivalence:
• Same product code (NGX), regulation number (21 CFR 890.5850), regulatory class (Class II), and clinical use (Prescription use).
• Identical Indications for Use (abdominal tone, muscle strengthening, toning, firming of buttocks/thighs/calves, muscle tone/firmness in arms).
• Similar Principle of Action (initiating action potential of nerves results in muscle contraction).
• Similar electrical protection, user interface, firmware control, type of energy (Magnetic field).
• Output parameters (Magnetic Field Intensity, Pulse Repetition Rate, Pulse Duration, Therapy Time) are within comparable ranges to the predicate device, with some minor differences noted (e.g., the subject device having 4 outputs vs. 2 for the predicate, and slightly different ranges for some magnetic field intensities and pulse durations, which the submission states have "no significant influence on safety or effectiveness"). |

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable. No clinical testing with a human test set was performed or submitted. The testing referenced is non-clinical (e.g., electrical safety, EMC, biocompatibility).
• Data Provenance: Not applicable for clinical data. For non-clinical testing, the data would originate from laboratory tests conducted by the manufacturer or their contracted testing facilities, likely in China (where the sponsor is located).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. No clinical study or human participant test set was used for this submission to establish ground truth based on expert review.

4. Adjudication Method for the Test Set:

Not applicable. No clinical study or human participant test set was used requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improvement with AI vs. Without AI Assistance:

Not applicable. This device is a "Body Contouring Machine" (a physical therapeutic device), not an AI-assisted diagnostic or interpretative software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The device is a physical medical device, not an algorithm or software requiring standalone performance evaluation in the context of diagnostic or interpretive tasks.

7. The Type of Ground Truth Used:

Not applicable in the clinical sense. The "ground truth" for this submission is based on adherence to recognized national and international standards for medical electrical equipment, biocompatibility, and risk management, as well as the substantial equivalence of its technical specifications and intended use to a legally marketed predicate device.

8. The Sample Size for the Training Set:

Not applicable. This device is a hardware-based medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As above, no training set was used.

Ask a specific question about this device