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FDA 510(k)

APEX MEDICAL DIGITAL TENS TS1211, TS1212

K-Number: K021755 · 2002-06-12

ApplicantApex Medical Corp.
Decision Date2002-06-12
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

APEX MEDICAL DIGITAL TENS TS1211, TS1212 is the device name listed in this FDA 510(k) record. The listed applicant is Apex Medical Corp.. It received FDA 510(k) clearance on 2002-06-12 under 510(k) number K021755. 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 APEX MEDICAL DIGITAL TENS TS1211, TS1212?

APEX MEDICAL DIGITAL TENS TS1211, TS1212 is a medical device that received FDA 510(k) clearance on 2002-06-12. The listed applicant is Apex Medical Corp.. The 510(k) number is K021755.

When did APEX MEDICAL DIGITAL TENS TS1211, TS1212 receive FDA 510(k) clearance?

APEX MEDICAL DIGITAL TENS TS1211, TS1212 received FDA 510(k) clearance on 2002-06-12, under 510(k) number K021755.

Who is the listed applicant for APEX MEDICAL DIGITAL TENS TS1211, TS1212?

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

What is the FDA product code for APEX MEDICAL DIGITAL TENS TS1211, TS1212?

The FDA product code for APEX MEDICAL DIGITAL TENS TS1211, TS1212 is GZJ.

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Other records listing Apex Medical Corp. as applicant

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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

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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