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FDA 510(k)

E-PAIN CARE

K-Number: K041714 · 2004-10-01

ApplicantBreg, Inc.
Decision Date2004-10-01
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

E-PAIN CARE is the device name listed in this FDA 510(k) record. The listed applicant is Breg, Inc.. It received FDA 510(k) clearance on 2004-10-01 under 510(k) number K041714. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-PAIN CARE?

E-PAIN CARE is a medical device that received FDA 510(k) clearance on 2004-10-01. The listed applicant is Breg, Inc.. The 510(k) number is K041714.

When did E-PAIN CARE receive FDA 510(k) clearance?

E-PAIN CARE received FDA 510(k) clearance on 2004-10-01, under 510(k) number K041714.

Who is the listed applicant for E-PAIN CARE?

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

What is the FDA product code for E-PAIN CARE?

The FDA product code for E-PAIN CARE is FRN.

Other records listing Breg, 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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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