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FDA 510(k)

MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER

K-Number: K963480 · 1997-01-22

ApplicantDeroyal Industries, Inc.
Decision Date1997-01-22
Product CodeKID
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 1997-01-22 under 510(k) number K963480. The device is classified under product code KID. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER?

MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K963480.

When did MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER receive FDA 510(k) clearance?

MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER received FDA 510(k) clearance on 1997-01-22, under 510(k) number K963480.

Who is the listed applicant for MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER?

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

What is the FDA product code for MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER?

The FDA product code for MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER is KID.

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Related Devices (Code: KID)

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.

K963479WHEELCHAIR BELTDeroyal Industries, Inc.K963475PONCHO VEST RESTRAINTDeroyal Industries, Inc.K963459SUPPORT VESTSkil-Care Corp.K963461SAFETY PONCHO/SHOULDER STRAP PONCHOSkil-Care Corp.K963455SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROLSkil-Care Corp.K802603ECONO-FLOAT WHEELCHAIR FLOTATION CUSHIONJefferson Industries, 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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