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FDA 510(k)

REMOTE SPEED CONTROL

K-Number: K851946 · 1985-07-19

ApplicantTh Charters, Inc.
Decision Date1985-07-19
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

REMOTE SPEED CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Th Charters, Inc.. It received FDA 510(k) clearance on 1985-07-19 under 510(k) number K851946. The device is classified under product code ISD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMOTE SPEED CONTROL?

REMOTE SPEED CONTROL is a medical device that received FDA 510(k) clearance on 1985-07-19. The listed applicant is Th Charters, Inc.. The 510(k) number is K851946.

When did REMOTE SPEED CONTROL receive FDA 510(k) clearance?

REMOTE SPEED CONTROL received FDA 510(k) clearance on 1985-07-19, under 510(k) number K851946.

Who is the listed applicant for REMOTE SPEED CONTROL?

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

What is the FDA product code for REMOTE SPEED CONTROL?

The FDA product code for REMOTE SPEED CONTROL is ISD.

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Other records listing Th Charters, Inc. as applicant

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Related Devices (Code: ISD)

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.

K202979MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal UltraLode B.V.K183296REAL Immersive SystemPenumbra, Inc.K112121ERGOSELECT/GEErgoline GmbHK080545ACTITRAINERActigraph, LLCK053078ERGOSELECT 100 K/P, ERGOSELECT 200 K/PErgoline GmbHK990866QUINTON MEDTRACK CR PLUS TREADMILLQuinton, 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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