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FDA 510(k)

RHS HELMET

K-Number: K012007 · 2001-09-19

ApplicantRestorative Health Svs, Inc.
Decision Date2001-09-19
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RHS HELMET is the device name listed in this FDA 510(k) record. The listed applicant is Restorative Health Svs, Inc.. It received FDA 510(k) clearance on 2001-09-19 under 510(k) number K012007. The device is classified under product code MVA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHS HELMET?

RHS HELMET is a medical device that received FDA 510(k) clearance on 2001-09-19. The listed applicant is Restorative Health Svs, Inc.. The 510(k) number is K012007.

When did RHS HELMET receive FDA 510(k) clearance?

RHS HELMET received FDA 510(k) clearance on 2001-09-19, under 510(k) number K012007.

Who is the listed applicant for RHS HELMET?

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

What is the FDA product code for RHS HELMET?

The FDA product code for RHS HELMET is MVA.

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Related Devices (Code: MVA)

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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