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FDA 510(k)

PROSANA BELT

K-Number: K812719 · 1981-10-06

ApplicantBandwagon, Inc.
Decision Date1981-10-06
Product CodeIQE
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PROSANA BELT is the device name listed in this FDA 510(k) record. The listed applicant is Bandwagon, Inc.. It received FDA 510(k) clearance on 1981-10-06 under 510(k) number K812719. The device is classified under product code IQE. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSANA BELT?

PROSANA BELT is a medical device that received FDA 510(k) clearance on 1981-10-06. The listed applicant is Bandwagon, Inc.. The 510(k) number is K812719.

When did PROSANA BELT receive FDA 510(k) clearance?

PROSANA BELT received FDA 510(k) clearance on 1981-10-06, under 510(k) number K812719.

Who is the listed applicant for PROSANA BELT?

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

What is the FDA product code for PROSANA BELT?

The FDA product code for PROSANA BELT is IQE.

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Related Devices (Code: IQE)

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.

K821682TRUNCAL ORTHOSISSurgical Appliance Industries, Inc.K820051OBUS FORME ORTHOPEDIC BRACE, UPRIGHTObus Forme, Ltd.K810450TRUNCAL ORTHOSISFred 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.

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