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FDA 510(k)

ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A

K-Number: K905571 · 1991-05-08

ApplicantBiomedical Life Systems, Inc.
Decision Date1991-05-08
Product CodeLIH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A 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 1991-05-08 under 510(k) number K905571. The device is classified under product code LIH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A?

ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A is a medical device that received FDA 510(k) clearance on 1991-05-08. The listed applicant is Biomedical Life Systems, Inc.. The 510(k) number is K905571.

When did ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A receive FDA 510(k) clearance?

ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A received FDA 510(k) clearance on 1991-05-08, under 510(k) number K905571.

Who is the listed applicant for ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A?

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 ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A?

The FDA product code for ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A is LIH.

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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: LIH)

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.

K231575Vecttor VT-300Artaflex, Inc.K202725ETD4000Therasigma, LLCK183692Avid IF2Vision Quest Industries Inc./Dba VQ OrthocareK122944GEMORE TRUE SINE INTERFERENTIAL STIMULATORGemore Technology Co, Ltd.K121662VECTTOR VT-200Alan Neuromedical Technologies, LLCK110509EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908Everyway Medical Instruments Co.,Ltd

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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