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FDA 510(k)

MODEL HS-2 TENS DEVICE

K-Number: K962951 · 1997-08-06

ApplicantTechnalithics Laboratories, Inc.
Decision Date1997-08-06
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL HS-2 TENS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Technalithics Laboratories, Inc.. It received FDA 510(k) clearance on 1997-08-06 under 510(k) number K962951. 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 MODEL HS-2 TENS DEVICE?

MODEL HS-2 TENS DEVICE is a medical device that received FDA 510(k) clearance on 1997-08-06. The listed applicant is Technalithics Laboratories, Inc.. The 510(k) number is K962951.

When did MODEL HS-2 TENS DEVICE receive FDA 510(k) clearance?

MODEL HS-2 TENS DEVICE received FDA 510(k) clearance on 1997-08-06, under 510(k) number K962951.

Who is the listed applicant for MODEL HS-2 TENS DEVICE?

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

What is the FDA product code for MODEL HS-2 TENS DEVICE?

The FDA product code for MODEL HS-2 TENS DEVICE is GZJ.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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