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FDA 510(k)

DYNA T-2000 PHYSICAL THERAPY SYSTEM

K-Number: K955808 · 1997-11-03

ApplicantThermia, Inc.
Decision Date1997-11-03
Product CodeIMB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DYNA T-2000 PHYSICAL THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Thermia, Inc.. It received FDA 510(k) clearance on 1997-11-03 under 510(k) number K955808. The device is classified under product code IMB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNA T-2000 PHYSICAL THERAPY SYSTEM?

DYNA T-2000 PHYSICAL THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1997-11-03. The listed applicant is Thermia, Inc.. The 510(k) number is K955808.

When did DYNA T-2000 PHYSICAL THERAPY SYSTEM receive FDA 510(k) clearance?

DYNA T-2000 PHYSICAL THERAPY SYSTEM received FDA 510(k) clearance on 1997-11-03, under 510(k) number K955808.

Who is the listed applicant for DYNA T-2000 PHYSICAL THERAPY SYSTEM?

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

What is the FDA product code for DYNA T-2000 PHYSICAL THERAPY SYSTEM?

The FDA product code for DYNA T-2000 PHYSICAL THERAPY SYSTEM is IMB.

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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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