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FDA 510(k)

AGAR 9K TENS

K-Number: K861894 · 1986-09-09

ApplicantSolcoor, Inc.
Decision Date1986-09-09
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AGAR 9K TENS is the device name listed in this FDA 510(k) record. The listed applicant is Solcoor, Inc.. It received FDA 510(k) clearance on 1986-09-09 under 510(k) number K861894. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AGAR 9K TENS?

AGAR 9K TENS is a medical device that received FDA 510(k) clearance on 1986-09-09. The listed applicant is Solcoor, Inc.. The 510(k) number is K861894.

When did AGAR 9K TENS receive FDA 510(k) clearance?

AGAR 9K TENS received FDA 510(k) clearance on 1986-09-09, under 510(k) number K861894.

Who is the listed applicant for AGAR 9K TENS?

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

What is the FDA product code for AGAR 9K TENS?

The FDA product code for AGAR 9K TENS is GZJ.

Other records listing Solcoor, 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.

View all 7 devices →

Related Devices (Code: GZJ)

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.

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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