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FDA 510(k)

ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M

K-Number: K020130 · 2002-12-02

ApplicantRolor Electronics Corp.
Decision Date2002-12-02
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M is the device name listed in this FDA 510(k) record. The listed applicant is Rolor Electronics Corp.. It received FDA 510(k) clearance on 2002-12-02 under 510(k) number K020130. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M?

ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M is a medical device that received FDA 510(k) clearance on 2002-12-02. The listed applicant is Rolor Electronics Corp.. The 510(k) number is K020130.

When did ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M receive FDA 510(k) clearance?

ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M received FDA 510(k) clearance on 2002-12-02, under 510(k) number K020130.

Who is the listed applicant for ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M?

The FDA 510(k) record lists Rolor Electronics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M?

The FDA product code for ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M is IPF.

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Other records listing Rolor Electronics Corp. 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.

K021430SANIDAD TENS-DUO MODE GP8016NK020464SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646K020462SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018

Related Devices (Code: IPF)

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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