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FDA 510(k)

SAFETY PONCHO/SHOULDER STRAP PONCHO

K-Number: K963461 · 1996-10-11

ApplicantSkil-Care Corp.
Decision Date1996-10-11
Product CodeKID
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SAFETY PONCHO/SHOULDER STRAP PONCHO is the device name listed in this FDA 510(k) record. The listed applicant is Skil-Care Corp.. It received FDA 510(k) clearance on 1996-10-11 under 510(k) number K963461. 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 SAFETY PONCHO/SHOULDER STRAP PONCHO?

SAFETY PONCHO/SHOULDER STRAP PONCHO is a medical device that received FDA 510(k) clearance on 1996-10-11. The listed applicant is Skil-Care Corp.. The 510(k) number is K963461.

When did SAFETY PONCHO/SHOULDER STRAP PONCHO receive FDA 510(k) clearance?

SAFETY PONCHO/SHOULDER STRAP PONCHO received FDA 510(k) clearance on 1996-10-11, under 510(k) number K963461.

Who is the listed applicant for SAFETY PONCHO/SHOULDER STRAP PONCHO?

The FDA 510(k) record lists Skil-Care Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFETY PONCHO/SHOULDER STRAP PONCHO?

The FDA product code for SAFETY PONCHO/SHOULDER STRAP PONCHO is KID.

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Other records listing Skil-Care Corp. 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.

K010818INFANT LIMB HOLDER, MODELS 306080 & 306081K010644CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025K963458PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTSK963459SUPPORT VESTK963460ROLL BELTK963457SLEEPER JACKET/HOUDINI SAFETY SLEEPER

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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.K963480MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDERDeroyal Industries, Inc.K963459SUPPORT VESTSkil-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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