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FDA 510(k)

ELPHA 2000 CONTI

K-Number: K964738 · 1997-08-14

ApplicantDan Med, Inc.
Decision Date1997-08-14
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ELPHA 2000 CONTI is the device name listed in this FDA 510(k) record. The listed applicant is Dan Med, Inc.. It received FDA 510(k) clearance on 1997-08-14 under 510(k) number K964738. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELPHA 2000 CONTI?

ELPHA 2000 CONTI is a medical device that received FDA 510(k) clearance on 1997-08-14. The listed applicant is Dan Med, Inc.. The 510(k) number is K964738.

When did ELPHA 2000 CONTI receive FDA 510(k) clearance?

ELPHA 2000 CONTI received FDA 510(k) clearance on 1997-08-14, under 510(k) number K964738.

Who is the listed applicant for ELPHA 2000 CONTI?

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

What is the FDA product code for ELPHA 2000 CONTI?

The FDA product code for ELPHA 2000 CONTI is KPI.

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Other records listing Dan Med, 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.

K013210TRUWAVEK012885NEUROMOVE NM900K010745EMS 3000K991241IF8000K972997AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION

Related Devices (Code: KPI)

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.

K262353BTL-299-FBTL Industries, Inc.K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)Hunan Accurate Bio-Medical Technology Co., Ltd.K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.K252831Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical Technology Co., Ltd.K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)Pontemedag

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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