← Product Code [INX](/productcode/INX) · K834344

# MED-OPEDIC SLEEP SYSTEM (K834344)

_Bemco Mattress Co. · INX · Jan 17, 1984 · Physical Medicine · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K834344

## Device Facts

- **Applicant:** Bemco Mattress Co.
- **Product Code:** [INX](/productcode/INX.md)
- **Decision Date:** Jan 17, 1984
- **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-staging.innolitics.com/device/K834344](https://fda-staging.innolitics.com/device/K834344)

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