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FDA 510(k)

KEGEL8 PELVIC EXERCISER, MODEL OPH 400

K-Number: K081480 · 2008-09-12

ApplicantNe Services , Ltd.
Decision Date2008-09-12
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KEGEL8 PELVIC EXERCISER, MODEL OPH 400 is the device name listed in this FDA 510(k) record. The listed applicant is Ne Services , Ltd.. It received FDA 510(k) clearance on 2008-09-12 under 510(k) number K081480. 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 KEGEL8 PELVIC EXERCISER, MODEL OPH 400?

KEGEL8 PELVIC EXERCISER, MODEL OPH 400 is a medical device that received FDA 510(k) clearance on 2008-09-12. The listed applicant is Ne Services , Ltd.. The 510(k) number is K081480.

When did KEGEL8 PELVIC EXERCISER, MODEL OPH 400 receive FDA 510(k) clearance?

KEGEL8 PELVIC EXERCISER, MODEL OPH 400 received FDA 510(k) clearance on 2008-09-12, under 510(k) number K081480.

Who is the listed applicant for KEGEL8 PELVIC EXERCISER, MODEL OPH 400?

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

What is the FDA product code for KEGEL8 PELVIC EXERCISER, MODEL OPH 400?

The FDA product code for KEGEL8 PELVIC EXERCISER, MODEL OPH 400 is KPI.

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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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