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FDA 510(k)

INFLATABLE FULL ARM SPLINT

K-Number: K874053 · 1987-11-23

ApplicantVinyl Technology, Inc.
Decision Date1987-11-23
Product CodeFZF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INFLATABLE FULL ARM SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Vinyl Technology, Inc.. It received FDA 510(k) clearance on 1987-11-23 under 510(k) number K874053. The device is classified under product code FZF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFLATABLE FULL ARM SPLINT?

INFLATABLE FULL ARM SPLINT is a medical device that received FDA 510(k) clearance on 1987-11-23. The listed applicant is Vinyl Technology, Inc.. The 510(k) number is K874053.

When did INFLATABLE FULL ARM SPLINT receive FDA 510(k) clearance?

INFLATABLE FULL ARM SPLINT received FDA 510(k) clearance on 1987-11-23, under 510(k) number K874053.

Who is the listed applicant for INFLATABLE FULL ARM SPLINT?

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

What is the FDA product code for INFLATABLE FULL ARM SPLINT?

The FDA product code for INFLATABLE FULL ARM SPLINT is FZF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Vinyl Technology, 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.

K874774TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERSK874051INFLATABLE FULL LEG SPLINTK874052INFLATABLE HALF LEG SPLINTK874050INFLATABLE FOOT & ANKLE SPLINT

Related Devices (Code: FZF)

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.

K881516COMPRESAIDR. Evans Corp.K874051INFLATABLE FULL LEG SPLINTVinyl Technology, Inc.K874052INFLATABLE HALF LEG SPLINTVinyl Technology, Inc.K874050INFLATABLE FOOT & ANKLE SPLINTVinyl Technology, Inc.K853600INFLATABLE AIR SPLINTSHospitak, Inc.K831764URIAS PRESSURE SPLINTS, & FIRST AIDSvenol Andersen

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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