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FDA 510(k)

PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE

K-Number: K830792 · 1983-03-29

ApplicantBomed Medical Mfr., Ltd.
Decision Date1983-03-29
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE is the device name listed in this FDA 510(k) record. The listed applicant is Bomed Medical Mfr., Ltd.. It received FDA 510(k) clearance on 1983-03-29 under 510(k) number K830792. 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 PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE?

PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE is a medical device that received FDA 510(k) clearance on 1983-03-29. The listed applicant is Bomed Medical Mfr., Ltd.. The 510(k) number is K830792.

When did PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE receive FDA 510(k) clearance?

PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE received FDA 510(k) clearance on 1983-03-29, under 510(k) number K830792.

Who is the listed applicant for PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE?

The FDA 510(k) record lists Bomed Medical Mfr., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE?

The FDA product code for PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE is GZJ.

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Other records listing Bomed Medical Mfr., Ltd. 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.

K853706BOMED-CDMK853705BOMED-EEAK831422BIOFLOWK831421BOMED BIOCONK813020BOMED-NCCOMK811999BO MED BIA

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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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