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K Number
K130385
Device Name
COMPRESSIBLE LIMB SLEEVE SYSTEM
Manufacturer
MAXSTAR INDUSTRIAL CO. LTD.
Date Cleared
2014-02-18

(368 days)

Product Code
IRP
Regulation Number
890.5650
Type
Traditional
Panel
Physical Medicine
Reference & Predicate Devices
N/A
Predicate For
K173158
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

UAM-8100 is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

Device Description

Compressible Limb Therapy System UAM-8100

AI/ML Overview

This document, a 510(k) clearance letter for the Compressible Limb Therapy System UAM-8100, does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The letter primarily:

  • Confirms that the FDA has reviewed the 510(k) premarket notification.
  • States that the device is substantially equivalent to legally marketed predicate devices.
  • Outlines post-market regulatory requirements (e.g., registration, labeling, adverse event reporting).
  • Provides the "Indications for Use" for the device.

Therefore, I cannot extract the following information from the provided text:

  1. A table of acceptance criteria and the reported device performance: This information is not present. The letter is a clearance for marketing, not a detailed technical report of performance.
  2. Sample size used for the test set and the data provenance: Not mentioned.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
  4. Adjudication method for the test set: Not mentioned.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
  6. If a standalone study was done: Not mentioned.
  7. The type of ground truth used: Not mentioned.
  8. The sample size for the training set: Not mentioned.
  9. How the ground truth for the training set was established: Not mentioned.

To obtain this type of information, one would typically need to review the actual 510(k) submission document itself, which contains the detailed technical and clinical study data submitted to the FDA for review. The letter provided is the FDA's decision based on that submission.

§ 890.5650 Powered inflatable tube massager.

(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).