Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ACU-STIM TENS, AP-101082T

K-Number: K973980 · 1998-07-29

ApplicantApex Medical Corp.
Decision Date1998-07-29
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACU-STIM TENS, AP-101082T 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 1998-07-29 under 510(k) number K973980. 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 ACU-STIM TENS, AP-101082T?

ACU-STIM TENS, AP-101082T is a medical device that received FDA 510(k) clearance on 1998-07-29. The listed applicant is Apex Medical Corp.. The 510(k) number is K973980.

When did ACU-STIM TENS, AP-101082T receive FDA 510(k) clearance?

ACU-STIM TENS, AP-101082T received FDA 510(k) clearance on 1998-07-29, under 510(k) number K973980.

Who is the listed applicant for ACU-STIM TENS, AP-101082T?

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 ACU-STIM TENS, AP-101082T?

The FDA product code for ACU-STIM TENS, AP-101082T is GZJ.

Other records listing Apex Medical 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.

K213577VenAir, Sequential Compression SystemK193206WiZARD 510 Nasal MaskK182394WiZARD 310/320 Series CPAP MaskK121642WIZARD 230 NASAL PILOW MASKK112079APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720K120035APEX MEDICAL ICH CPAP SERIES (9S-007XXX)

View all 28 devices →

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.

↑