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FDA 510(k)

SELF PROPELLED ROBOTIC WHEEL (SPRW)

K-Number: K950025 · 1996-09-03

ApplicantDatatran, Inc.
Decision Date1996-09-03
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SELF PROPELLED ROBOTIC WHEEL (SPRW) is the device name listed in this FDA 510(k) record. The listed applicant is Datatran, Inc.. It received FDA 510(k) clearance on 1996-09-03 under 510(k) number K950025. 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 SELF PROPELLED ROBOTIC WHEEL (SPRW)?

SELF PROPELLED ROBOTIC WHEEL (SPRW) is a medical device that received FDA 510(k) clearance on 1996-09-03. The listed applicant is Datatran, Inc.. The 510(k) number is K950025.

When did SELF PROPELLED ROBOTIC WHEEL (SPRW) receive FDA 510(k) clearance?

SELF PROPELLED ROBOTIC WHEEL (SPRW) received FDA 510(k) clearance on 1996-09-03, under 510(k) number K950025.

Who is the listed applicant for SELF PROPELLED ROBOTIC WHEEL (SPRW)?

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

What is the FDA product code for SELF PROPELLED ROBOTIC WHEEL (SPRW)?

The FDA product code for SELF PROPELLED ROBOTIC WHEEL (SPRW) is ITI.

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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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