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FDA 510(k)

DELUXE TRACTION EXERCISE GLOVE BK5035

K-Number: K831544 · 1983-06-24

ApplicantFred Sammons, Inc.
Decision Date1983-06-24
Product CodeIOD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DELUXE TRACTION EXERCISE GLOVE BK5035 is the device name listed in this FDA 510(k) record. The listed applicant is Fred Sammons, Inc.. It received FDA 510(k) clearance on 1983-06-24 under 510(k) number K831544. 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 DELUXE TRACTION EXERCISE GLOVE BK5035?

DELUXE TRACTION EXERCISE GLOVE BK5035 is a medical device that received FDA 510(k) clearance on 1983-06-24. The listed applicant is Fred Sammons, Inc.. The 510(k) number is K831544.

When did DELUXE TRACTION EXERCISE GLOVE BK5035 receive FDA 510(k) clearance?

DELUXE TRACTION EXERCISE GLOVE BK5035 received FDA 510(k) clearance on 1983-06-24, under 510(k) number K831544.

Who is the listed applicant for DELUXE TRACTION EXERCISE GLOVE BK5035?

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

What is the FDA product code for DELUXE TRACTION EXERCISE GLOVE BK5035?

The FDA product code for DELUXE TRACTION EXERCISE GLOVE BK5035 is IOD.

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Other records listing Fred Sammons, 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.

K880644ULTRA-PAN FOR ORTHOTIC PLASTICS (7262)K880647ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)K831549ARM SLINGSK831548SPLINTSK831550FINGER BONIOMETER BK7506K831542ADJUSTABLE POLYCENTRIC ELBOW HINGE

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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.

K823648SURGICAL TUBINGFred Sammons, Inc.K823822ANKLE WEIGHTSDanek Medical, Inc.K823600SOLID WOOD CONEFred Sammons, Inc.K813632COLOR CODED WEIGHT CUFFSFred Sammons, Inc.K812319THERAPY BENCHKaye Products, Inc.K790587CANVAS WEDGEMaddak, 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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