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FDA 510(k)

ZapStim Controller Application (Z1023)

K-Number: K233631 · 2024-02-09

ApplicantRevital Lab, Inc.
Decision Date2024-02-09
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ZapStim Controller Application (Z1023) is the device name listed in this FDA 510(k) record. The listed applicant is Revital Lab, Inc.. It received FDA 510(k) clearance on 2024-02-09 under 510(k) number K233631. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZapStim Controller Application (Z1023)?

ZapStim Controller Application (Z1023) is a medical device that received FDA 510(k) clearance on 2024-02-09. The listed applicant is Revital Lab, Inc.. The 510(k) number is K233631.

When did ZapStim Controller Application (Z1023) receive FDA 510(k) clearance?

ZapStim Controller Application (Z1023) received FDA 510(k) clearance on 2024-02-09, under 510(k) number K233631.

Who is the listed applicant for ZapStim Controller Application (Z1023)?

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

What is the FDA product code for ZapStim Controller Application (Z1023)?

The FDA product code for ZapStim Controller Application (Z1023) is OBP.

Related Devices (Code: OBP)

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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