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FDA 510(k)

TENS 4100

K-Number: K792502 · 1979-12-18

ApplicantStaodynamics, Inc.
Decision Date1979-12-18
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS 4100 is the device name listed in this FDA 510(k) record. The listed applicant is Staodynamics, Inc.. It received FDA 510(k) clearance on 1979-12-18 under 510(k) number K792502. 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 TENS 4100?

TENS 4100 is a medical device that received FDA 510(k) clearance on 1979-12-18. The listed applicant is Staodynamics, Inc.. The 510(k) number is K792502.

When did TENS 4100 receive FDA 510(k) clearance?

TENS 4100 received FDA 510(k) clearance on 1979-12-18, under 510(k) number K792502.

Who is the listed applicant for TENS 4100?

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

What is the FDA product code for TENS 4100?

The FDA product code for TENS 4100 is GZJ.

Other records listing Staodynamics, Inc. 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.

K852298TENS-AID STERILE ELECTRODES FOR POST-OP TENSK843964TENS-AID PREMIUM ELECTRODESK832988STAODYN EMS/PLUSK81328310D (TENS DEVICE)K813098TENS DEVICEK811345INSIGHT

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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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