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FDA 510(k)

WHEELCHAIR PATIENT RESTRAINTS

K-Number: K823816 · 1983-01-14

ApplicantDanek Medical, Inc.
Decision Date1983-01-14
Product CodeKNO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WHEELCHAIR PATIENT RESTRAINTS is the device name listed in this FDA 510(k) record. The listed applicant is Danek Medical, Inc.. It received FDA 510(k) clearance on 1983-01-14 under 510(k) number K823816. The device is classified under product code KNO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WHEELCHAIR PATIENT RESTRAINTS?

WHEELCHAIR PATIENT RESTRAINTS is a medical device that received FDA 510(k) clearance on 1983-01-14. The listed applicant is Danek Medical, Inc.. The 510(k) number is K823816.

When did WHEELCHAIR PATIENT RESTRAINTS receive FDA 510(k) clearance?

WHEELCHAIR PATIENT RESTRAINTS received FDA 510(k) clearance on 1983-01-14, under 510(k) number K823816.

Who is the listed applicant for WHEELCHAIR PATIENT RESTRAINTS?

The FDA 510(k) record lists Danek Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WHEELCHAIR PATIENT RESTRAINTS?

The FDA product code for WHEELCHAIR PATIENT RESTRAINTS is KNO.

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Other records listing Danek Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K994122BONE GRAFT WASHER, MODEL 9090114 - 9090118K993810CD HORIZON SPINAL SYSTEMK993855ATLANTIS ANTERIOR CERVICAL PLATE SYSTEMK991528MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTORK990603MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEMK982875MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM

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Related Devices (Code: KNO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K870298REDMAN ACCESSORIESRedman, Inc.K823646FRICTION FEEDERFred Sammons, Inc.K823645VELCRO STRAPS TO HOLD ARM TO WHEELCHAIRFred Sammons, Inc.K823635CUSHIONS FOR WHEELCHAIR ARMSFred Sammons, Inc.K823636ARM THROUGH FOR WHEELCHAIR BK-6459-01 &Fred Sammons, Inc.K823596CLAMP ON HOLDER FOR A GLASS OR CUPFred Sammons, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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