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FDA 510(k)

THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P)

K-Number: K932764 · 1993-10-01

ApplicantMyo/Kinetic Systems, Inc.
Decision Date1993-10-01
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P) is the device name listed in this FDA 510(k) record. The listed applicant is Myo/Kinetic Systems, Inc.. It received FDA 510(k) clearance on 1993-10-01 under 510(k) number K932764. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P)?

THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P) is a medical device that received FDA 510(k) clearance on 1993-10-01. The listed applicant is Myo/Kinetic Systems, Inc.. The 510(k) number is K932764.

When did THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P) receive FDA 510(k) clearance?

THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P) received FDA 510(k) clearance on 1993-10-01, under 510(k) number K932764.

Who is the listed applicant for THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P)?

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

What is the FDA product code for THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P)?

The FDA product code for THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P) is IPF.

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Other records listing Myo/Kinetic Systems, 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.

K945937TE-800 PELVIC FLOOR EXERCISERK945292TS-700P CONTROL XP ELECTRICAL STIMULATORK944972URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRYK936041UROGRAM CYSTOMETROGRAMK932611NEUROMUSCULAR STIMULATORK932399THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P)

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Related Devices (Code: IPF)

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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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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