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FDA 510(k)

TYPE 4000 TRANSCUTANEOUS ELEC. STIM.

K-Number: K800630 · 1980-04-02

ApplicantFrye Electronics, Inc.
Decision Date1980-04-02
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TYPE 4000 TRANSCUTANEOUS ELEC. STIM. is the device name listed in this FDA 510(k) record. The listed applicant is Frye Electronics, Inc.. It received FDA 510(k) clearance on 1980-04-02 under 510(k) number K800630. 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 TYPE 4000 TRANSCUTANEOUS ELEC. STIM.?

TYPE 4000 TRANSCUTANEOUS ELEC. STIM. is a medical device that received FDA 510(k) clearance on 1980-04-02. The listed applicant is Frye Electronics, Inc.. The 510(k) number is K800630.

When did TYPE 4000 TRANSCUTANEOUS ELEC. STIM. receive FDA 510(k) clearance?

TYPE 4000 TRANSCUTANEOUS ELEC. STIM. received FDA 510(k) clearance on 1980-04-02, under 510(k) number K800630.

Who is the listed applicant for TYPE 4000 TRANSCUTANEOUS ELEC. STIM.?

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

What is the FDA product code for TYPE 4000 TRANSCUTANEOUS ELEC. STIM.?

The FDA product code for TYPE 4000 TRANSCUTANEOUS ELEC. STIM. is GZJ.

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Other records listing Frye Electronics, 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.

K123701HEARLAB ACAK093006FONIX ,MODEL 8000K022510FONIX, MODEL 7000K980377FONIX FP35 HEARING AID ANALYZERK935400FONIX 3500 HEARING AID ANALYZERK913221TYPE FA10 AUDIOMETER

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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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