FDA 510(k)

ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)

K-Number: K963563 · 1996-11-21

Decision Date1996-11-21

Product CodeFMQ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145) is the device name listed in this FDA 510(k) record. The listed applicant is Tecnol Medical Products, Inc.. It received FDA 510(k) clearance on 1996-11-21 under 510(k) number K963563. The device is classified under product code FMQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)?

ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145) is a medical device that received FDA 510(k) clearance on 1996-11-21. The listed applicant is Tecnol Medical Products, Inc.. The 510(k) number is K963563.

When did ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145) receive FDA 510(k) clearance?

ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145) received FDA 510(k) clearance on 1996-11-21, under 510(k) number K963563.

Who is the listed applicant for ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)?

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

What is the FDA product code for ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)?

The FDA product code for ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145) is FMQ.

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Other records listing Tecnol Medical Products, Inc. as applicant

K974068PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL K970448PCM 2000; ISOLAIR APR MODEL 2735 K963559WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)K963552QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)K963564PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)K963556SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030)

View all 21 devices →

Related Devices (Code: FMQ)

K110377PROTECTIVE RESTRAINTMedi-Tech Intl. Corp.K081264STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002Children'S Health First, Inc.K080448CENTURION PROTECTIVE RESTRAINT, SCR SERIESTri-State Hospital Supply Corp.K013239COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLESMed Gen, Inc.K010818INFANT LIMB HOLDER, MODELS 306080 & 306081Skil-Care Corp.K010644CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025Skil-Care Corp.

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.