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FDA 510(k)

PONCHO VEST RESTRAINT

K-Number: K963475 · 1997-01-22

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

Device Summary

PONCHO VEST RESTRAINT 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 K963475. 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 PONCHO VEST RESTRAINT?

PONCHO VEST RESTRAINT 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 K963475.

When did PONCHO VEST RESTRAINT receive FDA 510(k) clearance?

PONCHO VEST RESTRAINT received FDA 510(k) clearance on 1997-01-22, under 510(k) number K963475.

Who is the listed applicant for PONCHO VEST RESTRAINT?

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 PONCHO VEST RESTRAINT?

The FDA product code for PONCHO VEST RESTRAINT is KID.

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Other records listing Deroyal Industries, Inc. as applicant

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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.K963480MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDERDeroyal 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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