← Product Code [INX](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/INX) · K884835

# TASSI MK2 (K884835)

_Therapy Air Support Systems, Inc. · INX · Dec 7, 1988 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/INX/K884835

## Device Facts

- **Applicant:** Therapy Air Support Systems, Inc.
- **Product Code:** [INX](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/INX.md)
- **Decision Date:** Dec 7, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5160
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

An air-fluidized bed is a device employing the circulation of filtered air through ceramic spherules (small, round ceramic objects) that is intended for medical purposes to treat or prevent bedsores, to treat severe or extensive burns, or to aid circulation.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/INX/K884835](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/INX/K884835)

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