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FDA 510(k)

THERAPEUTIC STIMULATOR 2100 (TS-2100)

K-Number: K914904 · 1992-04-28

ApplicantMyo/Kinetic Systems, Inc.
Decision Date1992-04-28
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERAPEUTIC STIMULATOR 2100 (TS-2100) 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 1992-04-28 under 510(k) number K914904. 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 2100 (TS-2100)?

THERAPEUTIC STIMULATOR 2100 (TS-2100) is a medical device that received FDA 510(k) clearance on 1992-04-28. The listed applicant is Myo/Kinetic Systems, Inc.. The 510(k) number is K914904.

When did THERAPEUTIC STIMULATOR 2100 (TS-2100) receive FDA 510(k) clearance?

THERAPEUTIC STIMULATOR 2100 (TS-2100) received FDA 510(k) clearance on 1992-04-28, under 510(k) number K914904.

Who is the listed applicant for THERAPEUTIC STIMULATOR 2100 (TS-2100)?

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 2100 (TS-2100)?

The FDA product code for THERAPEUTIC STIMULATOR 2100 (TS-2100) 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 STIMULATORK932764THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P)

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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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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