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FDA 510(k)

ACCU-PULSE TENS UNIT

K-Number: K010203 · 2001-08-28

ApplicantSadler Electronics
Decision Date2001-08-28
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACCU-PULSE TENS UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Sadler Electronics. It received FDA 510(k) clearance on 2001-08-28 under 510(k) number K010203. 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 ACCU-PULSE TENS UNIT?

ACCU-PULSE TENS UNIT is a medical device that received FDA 510(k) clearance on 2001-08-28. The listed applicant is Sadler Electronics. The 510(k) number is K010203.

When did ACCU-PULSE TENS UNIT receive FDA 510(k) clearance?

ACCU-PULSE TENS UNIT received FDA 510(k) clearance on 2001-08-28, under 510(k) number K010203.

Who is the listed applicant for ACCU-PULSE TENS UNIT?

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

What is the FDA product code for ACCU-PULSE TENS UNIT?

The FDA product code for ACCU-PULSE TENS UNIT is GZJ.

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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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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