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FDA 510(k)

ELECTRICAL MUSCLE STIMULATOR (EMS)

K-Number: K800068 · 1980-02-05

ApplicantStaodynamics, Inc.
Decision Date1980-02-05
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ELECTRICAL MUSCLE STIMULATOR (EMS) is the device name listed in this FDA 510(k) record. The listed applicant is Staodynamics, Inc.. It received FDA 510(k) clearance on 1980-02-05 under 510(k) number K800068. 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 ELECTRICAL MUSCLE STIMULATOR (EMS)?

ELECTRICAL MUSCLE STIMULATOR (EMS) is a medical device that received FDA 510(k) clearance on 1980-02-05. The listed applicant is Staodynamics, Inc.. The 510(k) number is K800068.

When did ELECTRICAL MUSCLE STIMULATOR (EMS) receive FDA 510(k) clearance?

ELECTRICAL MUSCLE STIMULATOR (EMS) received FDA 510(k) clearance on 1980-02-05, under 510(k) number K800068.

Who is the listed applicant for ELECTRICAL MUSCLE STIMULATOR (EMS)?

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

What is the FDA product code for ELECTRICAL MUSCLE STIMULATOR (EMS)?

The FDA product code for ELECTRICAL MUSCLE STIMULATOR (EMS) is IPF.

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 Staodynamics, 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.

K852298TENS-AID STERILE ELECTRODES FOR POST-OP TENSK843964TENS-AID PREMIUM ELECTRODESK832988STAODYN EMS/PLUSK81328310D (TENS DEVICE)K813098TENS DEVICEK811345INSIGHT

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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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