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FDA 510(k)

E.W.L. P-TENS/H-WAVE

K-Number: K862121 · 1987-06-17

ApplicantElectronic Waveform Laboratory, Inc.
Decision Date1987-06-17
Product CodeKZM
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

E.W.L. P-TENS/H-WAVE is the device name listed in this FDA 510(k) record. The listed applicant is Electronic Waveform Laboratory, Inc.. It received FDA 510(k) clearance on 1987-06-17 under 510(k) number K862121. The device is classified under product code KZM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E.W.L. P-TENS/H-WAVE?

E.W.L. P-TENS/H-WAVE is a medical device that received FDA 510(k) clearance on 1987-06-17. The listed applicant is Electronic Waveform Laboratory, Inc.. The 510(k) number is K862121.

When did E.W.L. P-TENS/H-WAVE receive FDA 510(k) clearance?

E.W.L. P-TENS/H-WAVE received FDA 510(k) clearance on 1987-06-17, under 510(k) number K862121.

Who is the listed applicant for E.W.L. P-TENS/H-WAVE?

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

What is the FDA product code for E.W.L. P-TENS/H-WAVE?

The FDA product code for E.W.L. P-TENS/H-WAVE is KZM.

Other records listing Electronic Waveform Laboratory, 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.

K103738H-WAVEK081998H-WAVE SPORTK915230H WAVE MUSCLE STIMULATORK873604E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRYK813601E.W.L. P-TENS MODEL(TENS

Related Devices (Code: KZM)

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.

K161716TEETHAN 2.0Bts S.P.A.K130158M-SCANBio-Research Associates, Inc.K113677GRINDCARE MEASUREMedotech A/SK082927BIOEMG IIIBio-Research Associates, Inc.K043373DOLOTENS DENTAL TM 1Neuromuscular Technologies, Inc.K030869BITESTRIPS.L.P. , Ltd.

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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