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FDA 510(k)

STONEHEART ROLLER AID

K-Number: K925247 · 1993-02-12

ApplicantStoneheart, Inc.
Decision Date1993-02-12
Product CodeINM
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STONEHEART ROLLER AID is the device name listed in this FDA 510(k) record. The listed applicant is Stoneheart, Inc.. It received FDA 510(k) clearance on 1993-02-12 under 510(k) number K925247. The device is classified under product code INM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STONEHEART ROLLER AID?

STONEHEART ROLLER AID is a medical device that received FDA 510(k) clearance on 1993-02-12. The listed applicant is Stoneheart, Inc.. The 510(k) number is K925247.

When did STONEHEART ROLLER AID receive FDA 510(k) clearance?

STONEHEART ROLLER AID received FDA 510(k) clearance on 1993-02-12, under 510(k) number K925247.

Who is the listed applicant for STONEHEART ROLLER AID?

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

What is the FDA product code for STONEHEART ROLLER AID?

The FDA product code for STONEHEART ROLLER AID is INM.

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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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