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FDA 510(k)

STIMTECH PFX, CATALOG NUMBER 78-8540

K-Number: K922562 · 1993-10-13

ApplicantStimtech Products
Decision Date1993-10-13
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STIMTECH PFX, CATALOG NUMBER 78-8540 is the device name listed in this FDA 510(k) record. The listed applicant is Stimtech Products. It received FDA 510(k) clearance on 1993-10-13 under 510(k) number K922562. 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 STIMTECH PFX, CATALOG NUMBER 78-8540?

STIMTECH PFX, CATALOG NUMBER 78-8540 is a medical device that received FDA 510(k) clearance on 1993-10-13. The listed applicant is Stimtech Products. The 510(k) number is K922562.

When did STIMTECH PFX, CATALOG NUMBER 78-8540 receive FDA 510(k) clearance?

STIMTECH PFX, CATALOG NUMBER 78-8540 received FDA 510(k) clearance on 1993-10-13, under 510(k) number K922562.

Who is the listed applicant for STIMTECH PFX, CATALOG NUMBER 78-8540?

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

What is the FDA product code for STIMTECH PFX, CATALOG NUMBER 78-8540?

The FDA product code for STIMTECH PFX, CATALOG NUMBER 78-8540 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 Stimtech Products 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.

K903128STIMTRAC PC, CATALOG NO. 78-8510K895671STIMTRAC II CATALOG NUMBER 78-8500

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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