Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VELCRO SPLINT STRAP FASTENERS

K-Number: K812655 · 1981-09-25

ApplicantMaddak, Inc.
Decision Date1981-09-25
Product CodeILH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

VELCRO SPLINT STRAP FASTENERS is the device name listed in this FDA 510(k) record. The listed applicant is Maddak, Inc.. It received FDA 510(k) clearance on 1981-09-25 under 510(k) number K812655. The device is classified under product code ILH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VELCRO SPLINT STRAP FASTENERS?

VELCRO SPLINT STRAP FASTENERS is a medical device that received FDA 510(k) clearance on 1981-09-25. The listed applicant is Maddak, Inc.. The 510(k) number is K812655.

When did VELCRO SPLINT STRAP FASTENERS receive FDA 510(k) clearance?

VELCRO SPLINT STRAP FASTENERS received FDA 510(k) clearance on 1981-09-25, under 510(k) number K812655.

Who is the listed applicant for VELCRO SPLINT STRAP FASTENERS?

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

What is the FDA product code for VELCRO SPLINT STRAP FASTENERS?

The FDA product code for VELCRO SPLINT STRAP FASTENERS is ILH.

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 Maddak, 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.

K841700WALK & ROLLK841698HEAT PACKK841695CRAWLERK841697HYDRO-THERO PADK841693STANDING FRAMEK841692PRONE STANDER

View all 51 devices →

Related Devices (Code: ILH)

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.

K832144SPLINT WOODVermont Wood Industries, Inc.K831548SPLINTSFred Sammons, Inc.K823647FINGER EXTENSION SPLINTFred Sammons, Inc.K823644FINGER FLEXION SPLINTFred Sammons, Inc.K823666UNIVERSAL WRIST SPLINT & FOREARM SPLINTWarm & Form, Orthopedic MaterialsK823601WRIST SUPPORTFred Sammons, 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.

↑