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FDA 510(k)

INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER

K-Number: K974048 · 1997-12-23

ApplicantHollister, Inc.
Decision Date1997-12-23
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1997-12-23 under 510(k) number K974048. 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 INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER?

INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER is a medical device that received FDA 510(k) clearance on 1997-12-23. The listed applicant is Hollister, Inc.. The 510(k) number is K974048.

When did INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER receive FDA 510(k) clearance?

INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER received FDA 510(k) clearance on 1997-12-23, under 510(k) number K974048.

Who is the listed applicant for INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER?

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

What is the FDA product code for INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER?

The FDA product code for INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER is KPI.

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Other records listing Hollister, Inc. as applicant

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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

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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