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FDA 510(k)

NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM

K-Number: K973096 · 1998-06-12

ApplicantNeotonus, Inc.
Decision Date1998-06-12
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Neotonus, Inc.. It received FDA 510(k) clearance on 1998-06-12 under 510(k) number K973096. 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 NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM?

NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM is a medical device that received FDA 510(k) clearance on 1998-06-12. The listed applicant is Neotonus, Inc.. The 510(k) number is K973096.

When did NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM receive FDA 510(k) clearance?

NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM received FDA 510(k) clearance on 1998-06-12, under 510(k) number K973096.

Who is the listed applicant for NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM?

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

What is the FDA product code for NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM?

The FDA product code for NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM is KPI.

Related Clinical Trials

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.

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Other records listing Neotonus, 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.

K002889PNS MAGNETIC STIMULATOR SYSTEMK001903NEOCONTROL PELVIC FLOOR THERAPY SYSTEMK973929NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM

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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