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FDA 510(k)

SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES

K-Number: K011913 · 2001-10-26

ApplicantSun-Rain System Corp.
Decision Date2001-10-26
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Sun-Rain System Corp.. It received FDA 510(k) clearance on 2001-10-26 under 510(k) number K011913. 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 SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES?

SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES is a medical device that received FDA 510(k) clearance on 2001-10-26. The listed applicant is Sun-Rain System Corp.. The 510(k) number is K011913.

When did SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES receive FDA 510(k) clearance?

SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES received FDA 510(k) clearance on 2001-10-26, under 510(k) number K011913.

Who is the listed applicant for SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES?

The FDA 510(k) record lists Sun-Rain System Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES?

The FDA product code for SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES is IPF.

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Other records listing Sun-Rain System 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.

K090542SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900K024013SUN-RAIN ULTRASONIC THERAPY, SU-100

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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