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FDA 510(k)

ROLL AID

K-Number: K970164 · 1997-04-15

ApplicantStand Aid of Iowa, Inc.
Decision Date1997-04-15
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ROLL AID is the device name listed in this FDA 510(k) record. The listed applicant is Stand Aid of Iowa, Inc.. It received FDA 510(k) clearance on 1997-04-15 under 510(k) number K970164. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROLL AID?

ROLL AID is a medical device that received FDA 510(k) clearance on 1997-04-15. The listed applicant is Stand Aid of Iowa, Inc.. The 510(k) number is K970164.

When did ROLL AID receive FDA 510(k) clearance?

ROLL AID received FDA 510(k) clearance on 1997-04-15, under 510(k) number K970164.

Who is the listed applicant for ROLL AID?

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

What is the FDA product code for ROLL AID?

The FDA product code for ROLL AID is ITI.

Other records listing Stand Aid of Iowa, Inc. as applicant

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.

K872934STAND AID

Related Devices (Code: ITI)

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.

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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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