Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT

K-Number: K893994 · 1989-12-14

ApplicantRich-Mar Corp.
Decision Date1989-12-14
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Rich-Mar Corp.. It received FDA 510(k) clearance on 1989-12-14 under 510(k) number K893994. 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 IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT?

IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT is a medical device that received FDA 510(k) clearance on 1989-12-14. The listed applicant is Rich-Mar Corp.. The 510(k) number is K893994.

When did IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT receive FDA 510(k) clearance?

IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT received FDA 510(k) clearance on 1989-12-14, under 510(k) number K893994.

Who is the listed applicant for IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT?

The FDA 510(k) record lists Rich-Mar Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT?

The FDA product code for IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Rich-Mar Corp. 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.

K040679RICH-MAR AUTOPRISM INFRARED LAMPK031018AUTOGEL PADK032941AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICEK021483RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUNDK013770MODIFICATION TO: WINNER ST-2 STIMULATORK013771MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE

View all 43 devices →

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.

↑