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)

US 610

K-Number: K844036 · 1984-11-27

ApplicantRich-Mar Corp.
Decision Date1984-11-27
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

US 610 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 1984-11-27 under 510(k) number K844036. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the US 610?

US 610 is a medical device that received FDA 510(k) clearance on 1984-11-27. The listed applicant is Rich-Mar Corp.. The 510(k) number is K844036.

When did US 610 receive FDA 510(k) clearance?

US 610 received FDA 510(k) clearance on 1984-11-27, under 510(k) number K844036.

Who is the listed applicant for US 610?

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 US 610?

The FDA product code for US 610 is IMI.

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: IMI)

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.

K240788Ultrasound StimulatorJkh Health Co., Ltd.K230472Sonopuls 190Enraf-Nonius, B.V.K222098ManaSport+Manamed, Inc.K210284ManaSportManamed, Inc.K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E OrtoK160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical , Ltd.

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.

↑