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FDA 510(k)

3-D PASSIVE MOBILIZER

K-Number: K834360 · 1984-01-13

Applicant3-D Orthopedic, Inc.
Decision Date1984-01-13
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

3-D PASSIVE MOBILIZER is the device name listed in this FDA 510(k) record. The listed applicant is 3-D Orthopedic, Inc.. It received FDA 510(k) clearance on 1984-01-13 under 510(k) number K834360. 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 3-D PASSIVE MOBILIZER?

3-D PASSIVE MOBILIZER is a medical device that received FDA 510(k) clearance on 1984-01-13. The listed applicant is 3-D Orthopedic, Inc.. The 510(k) number is K834360.

When did 3-D PASSIVE MOBILIZER receive FDA 510(k) clearance?

3-D PASSIVE MOBILIZER received FDA 510(k) clearance on 1984-01-13, under 510(k) number K834360.

Who is the listed applicant for 3-D PASSIVE MOBILIZER?

The FDA 510(k) record lists 3-D Orthopedic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3-D PASSIVE MOBILIZER?

The FDA product code for 3-D PASSIVE MOBILIZER is ISD.

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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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