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Paraplegic Bed

by Wayne V. Kirkman

510(k) K790049

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK790049 Date27 Feb 1979ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Bed, Paraplegic
510(k) Number
FDA Product Code
FNL
Device Class
Class II
Regulation
21 CFR Part 880.5100
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Paraplegic Bed is a hospital bed designed for patients with paraplegia, providing adjustable positioning and support to accommodate mobility limitations. It falls under the classification of an adjustable hospital bed, tailored for specialized medical use in general hospital settings. The device incorporates mechanical adjustments to facilitate patient care and comfort, ensuring proper alignment and reducing strain on caregivers.

This bed is supplied as a reusable medical device, intended for use in clinical environments where paraplegic patients require long-term support. It is not classified as single-use and must be cleaned and maintained according to standard hospital protocols. The device is regulated under FDA 510(k) clearance (K790049) with a classification under product code FNL, granted as substantially equivalent to a predicate device. No additional sterility or MRI safety information is provided in the specifications.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Paraplegic Bed designed for?

    The Paraplegic Bed is specifically designed for patients with paraplegia, providing adjustable mechanical positioning to support mobility limitations. Its features ensure proper alignment, reduce caregiver strain, and enhance patient comfort during long-term clinical use in general hospital settings.

  • Is the Paraplegic Bed reusable or single-use?

    This bed is a reusable medical device. It is intended for repeated use in clinical environments and must be cleaned and maintained according to standard hospital protocols to ensure hygiene and functionality.

  • What regulatory clearance does the Paraplegic Bed hold?

    The Paraplegic Bed holds FDA 510(k) clearance under the reference number K790049. It is classified under product code FNL and is deemed substantially equivalent to a predicate device through a traditional clearance process.

  • Does the Paraplegic Bed require special storage or handling?

    While no specific sterility requirements are mentioned, the bed is a reusable device and should be stored in a clean, dry environment when not in use. Regular maintenance and adherence to hospital cleaning protocols are essential to preserve its functionality and ensure patient safety.

  • What type of adjustments does the Paraplegic Bed offer?

    The bed incorporates mechanical adjustments to facilitate patient care. These adjustments allow for customizable positioning and support, tailored to accommodate the specific needs of paraplegic patients for improved comfort and alignment.