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FDA 510(k)

NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE

K-Number: K831850 · 1983-07-19

ApplicantTh Charters, Inc.
Decision Date1983-07-19
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE is the device name listed in this FDA 510(k) record. The listed applicant is Th Charters, Inc.. It received FDA 510(k) clearance on 1983-07-19 under 510(k) number K831850. 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 NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE?

NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is Th Charters, Inc.. The 510(k) number is K831850.

When did NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE receive FDA 510(k) clearance?

NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE received FDA 510(k) clearance on 1983-07-19, under 510(k) number K831850.

Who is the listed applicant for NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE?

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

What is the FDA product code for NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE?

The FDA product code for NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE is GZJ.

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Other records listing Th Charters, 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.

K873357ELECTROBLOC TRANS. ELECTRICAL NERVE BLOCK GENERA.K861501EXER-STIM 2K851946REMOTE SPEED CONTROLK851967TORQUE FEEDBACK METERK834215MINI-1 TRANSCUTANEOUS ELEC-NERVE STIMK822056EXER-STIM CONTROLLER

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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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