← Product Code [KPJ](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ) · K920948

# TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER (K920948)

_Topox Therapeuutic Rentals, Inc. · KPJ · Aug 11, 1992 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K920948

## Device Facts

- **Applicant:** Topox Therapeuutic Rentals, Inc.
- **Product Code:** [KPJ](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ.md)
- **Decision Date:** Aug 11, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.5650
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory 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.

## Special Controls

*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.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K920948](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/KPJ/K920948)

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