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FDA 510(k)

THERA PULSE A ELECTRO NERVE STIMULATOR

K-Number: K925686 · 1993-03-18

ApplicantBiomedical Life Systems, Inc.
Decision Date1993-03-18
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

THERA PULSE A ELECTRO NERVE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Life Systems, Inc.. It received FDA 510(k) clearance on 1993-03-18 under 510(k) number K925686. 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 THERA PULSE A ELECTRO NERVE STIMULATOR?

THERA PULSE A ELECTRO NERVE STIMULATOR is a medical device that received FDA 510(k) clearance on 1993-03-18. The listed applicant is Biomedical Life Systems, Inc.. The 510(k) number is K925686.

When did THERA PULSE A ELECTRO NERVE STIMULATOR receive FDA 510(k) clearance?

THERA PULSE A ELECTRO NERVE STIMULATOR received FDA 510(k) clearance on 1993-03-18, under 510(k) number K925686.

Who is the listed applicant for THERA PULSE A ELECTRO NERVE STIMULATOR?

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

What is the FDA product code for THERA PULSE A ELECTRO NERVE STIMULATOR?

The FDA product code for THERA PULSE A ELECTRO NERVE STIMULATOR is GZJ.

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Other records listing Biomedical Life Systems, 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.

K172971BMLS16-1K102051PAIN BUDDYK061476ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1K042711MODEL BMLS03-7K041388COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1K040007INTERFERENTIAL STIMULATOR, MODEL BMLS02-6

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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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