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FDA 510(k)

FLEXION MITTENS

K-Number: K771030 · 1977-06-27

ApplicantStat Medical Corp.
Decision Date1977-06-27
Product CodeIOD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FLEXION MITTENS is the device name listed in this FDA 510(k) record. The listed applicant is Stat Medical Corp.. It received FDA 510(k) clearance on 1977-06-27 under 510(k) number K771030. The device is classified under product code IOD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXION MITTENS?

FLEXION MITTENS is a medical device that received FDA 510(k) clearance on 1977-06-27. The listed applicant is Stat Medical Corp.. The 510(k) number is K771030.

When did FLEXION MITTENS receive FDA 510(k) clearance?

FLEXION MITTENS received FDA 510(k) clearance on 1977-06-27, under 510(k) number K771030.

Who is the listed applicant for FLEXION MITTENS?

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

What is the FDA product code for FLEXION MITTENS?

The FDA product code for FLEXION MITTENS is IOD.

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.

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Other records listing Stat Medical 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.

K780171ELBOW PROTECTORK771031STROKE SLINGK770853STERILE COTTON

Related Devices (Code: IOD)

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.

K831544DELUXE TRACTION EXERCISE GLOVE BK5035Fred Sammons, Inc.K823648SURGICAL TUBINGFred Sammons, Inc.K823822ANKLE WEIGHTSDanek Medical, Inc.K823600SOLID WOOD CONEFred Sammons, Inc.K813632COLOR CODED WEIGHT CUFFSFred Sammons, Inc.K812319THERAPY BENCHKaye Products, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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