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K Number
K963777
Device Name
HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100
Manufacturer
STEPHENSON INDUSTRIES, INC.
Date Cleared
1997-07-28

(311 days)

Product Code
KPJ
Regulation Number
878.5650
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • VENOUS STASIS S
  • DECUBITUS STASIS UL CERS
  • DIABETIC ULCERS
  • вики с
  • FROSTBITE
    -POST SURGICAL WOUNDS
Device Description

Hyper Pulse Intermittent Topical Oxygen Chamber, Models C-100; CB-100

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) letter for the "Hyper Pulse Intermittent Topical Oxygen Chamber" does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.

This document is a letter confirming the substantial equivalence of the device to a predicate device, allowing it to be marketed. It outlines the regulatory classification and general controls applicable to the device but does not detail any performance studies, test sets, ground truth establishment, or clinical effectiveness data.

§ 878.5650 Topical oxygen chamber for extremities.

(a)
Identification. A topical oxygen chamber for extremities is a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities.” See § 878.1(e) for the availability of this guidance document.