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K Number
K210284
Device Name
ManaSport
Manufacturer
ManaMed, Inc.
Date Cleared
2022-04-26

(448 days)

Product Code
IMI,PFW
Regulation Number
890.5300
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Apply stationary use of ultrasound to:

Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

Apply continuous movement of ultrasound for:

  1. Pain.
    1. Pain relief, muscle spasms, and joint contractures.
    1. Relief of pain, muscle spasms, and joint contractures that may be associated with:
  • · Adhesive capsulitis.
  • · Bursitis with slight calcification,
  • · Myositis,
  • · Soft tissue injuries, and
  • · Shortened tendons due to past injuries and scar tissues.
    1. Relief of pain, muscle spasms, and joint contractures resulting from:
  • · Capsular tightness, and
  • · Capsular scarring.
    1. Localized increase in blood flow.
    1. Increased range of motion of contracted joint using heat and stretch techniques.
Device Description

Not Found

AI/ML Overview

This is a medical device clearance letter for the ManaSport ultrasonic diathermy device. The provided text is not a clinical study report and does not contain the information requested about acceptance criteria, study design, or performance metrics for an AI/algorithm-based device.

The document discusses the regulatory clearance process for a traditional medical device (ultrasonic diathermy) under a 510(k) submission, confirming its substantial equivalence to previously marketed devices. It outlines general regulatory requirements and lists the device's indications for use.

Therefore, I cannot provide the requested information, such as:

  1. Table of acceptance criteria and reported device performance: This information is not present.
  2. Sample size for test set and data provenance: Not applicable to this type of regulatory document.
  3. Number of experts and qualifications for ground truth: Not applicable.
  4. Adjudication method: Not applicable.
  5. MRMC comparative effectiveness study or effect size: This is not an AI-assisted device, so this is not relevant.
  6. Standalone (algorithm only) performance: This device is not an algorithm.
  7. Type of ground truth used: Not applicable.
  8. Sample size for training set: Not applicable.
  9. How ground truth for training set was established: Not applicable.

The document focuses on the regulatory clearance of a physical device, not the performance evaluation of an AI algorithm.

§ 890.5300 Ultrasonic diathermy.

(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.