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FDA 510(k)

TENS PALS PLUS

K-Number: K872976 · 1987-09-22

ApplicantAxelgaard Mfg. Co., Ltd.
Decision Date1987-09-22
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS PALS PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Axelgaard Mfg. Co., Ltd.. It received FDA 510(k) clearance on 1987-09-22 under 510(k) number K872976. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENS PALS PLUS?

TENS PALS PLUS is a medical device that received FDA 510(k) clearance on 1987-09-22. The listed applicant is Axelgaard Mfg. Co., Ltd.. The 510(k) number is K872976.

When did TENS PALS PLUS receive FDA 510(k) clearance?

TENS PALS PLUS received FDA 510(k) clearance on 1987-09-22, under 510(k) number K872976.

Who is the listed applicant for TENS PALS PLUS?

The FDA 510(k) record lists Axelgaard Mfg. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS PALS PLUS?

The FDA product code for TENS PALS PLUS is GXY.

Other records listing Axelgaard Mfg. Co., Ltd. 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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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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