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FDA 510(k)

MYOMO E100

K-Number: K062631 · 2007-04-12

ApplicantMyomo, Inc.
Decision Date2007-04-12
Product CodeOAL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MYOMO E100 is the device name listed in this FDA 510(k) record. The listed applicant is Myomo, Inc.. It received FDA 510(k) clearance on 2007-04-12 under 510(k) number K062631. The device is classified under product code OAL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYOMO E100?

MYOMO E100 is a medical device that received FDA 510(k) clearance on 2007-04-12. The listed applicant is Myomo, Inc.. The 510(k) number is K062631.

When did MYOMO E100 receive FDA 510(k) clearance?

MYOMO E100 received FDA 510(k) clearance on 2007-04-12, under 510(k) number K062631.

Who is the listed applicant for MYOMO E100?

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

What is the FDA product code for MYOMO E100?

The FDA product code for MYOMO E100 is OAL.

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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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