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FDA 510(k)

DUAL CHANNEL TENS, PULSAR REMOTE CONTRL

K-Number: K842888 · 1985-01-14

ApplicantCryomedics, Inc.
Decision Date1985-01-14
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DUAL CHANNEL TENS, PULSAR REMOTE CONTRL is the device name listed in this FDA 510(k) record. The listed applicant is Cryomedics, Inc.. It received FDA 510(k) clearance on 1985-01-14 under 510(k) number K842888. 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 DUAL CHANNEL TENS, PULSAR REMOTE CONTRL?

DUAL CHANNEL TENS, PULSAR REMOTE CONTRL is a medical device that received FDA 510(k) clearance on 1985-01-14. The listed applicant is Cryomedics, Inc.. The 510(k) number is K842888.

When did DUAL CHANNEL TENS, PULSAR REMOTE CONTRL receive FDA 510(k) clearance?

DUAL CHANNEL TENS, PULSAR REMOTE CONTRL received FDA 510(k) clearance on 1985-01-14, under 510(k) number K842888.

Who is the listed applicant for DUAL CHANNEL TENS, PULSAR REMOTE CONTRL?

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

What is the FDA product code for DUAL CHANNEL TENS, PULSAR REMOTE CONTRL?

The FDA product code for DUAL CHANNEL TENS, PULSAR REMOTE CONTRL is GZJ.

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Other records listing Cryomedics, Inc. as applicant

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K851152MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULARK844431YN CO2 LASER SYSTEM 30WK842959MC-4000 CONSOLE & PROBESK842704MT-700 MT-750 FT-350K801730KRYMED SYSTEM 4001 TILT SCOPEK800335KRYMED LIQUID NITROGEN CRYOJET

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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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