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)

TRU-TECH 310 ULTRASOUND THERAPY UNIT #310

K-Number: K881211 · 1988-05-11

ApplicantTru-Trac Therapy Products, Inc.
Decision Date1988-05-11
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TRU-TECH 310 ULTRASOUND THERAPY UNIT #310 is the device name listed in this FDA 510(k) record. The listed applicant is Tru-Trac Therapy Products, Inc.. It received FDA 510(k) clearance on 1988-05-11 under 510(k) number K881211. 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 TRU-TECH 310 ULTRASOUND THERAPY UNIT #310?

TRU-TECH 310 ULTRASOUND THERAPY UNIT #310 is a medical device that received FDA 510(k) clearance on 1988-05-11. The listed applicant is Tru-Trac Therapy Products, Inc.. The 510(k) number is K881211.

When did TRU-TECH 310 ULTRASOUND THERAPY UNIT #310 receive FDA 510(k) clearance?

TRU-TECH 310 ULTRASOUND THERAPY UNIT #310 received FDA 510(k) clearance on 1988-05-11, under 510(k) number K881211.

Who is the listed applicant for TRU-TECH 310 ULTRASOUND THERAPY UNIT #310?

The FDA 510(k) record lists Tru-Trac Therapy Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRU-TECH 310 ULTRASOUND THERAPY UNIT #310?

The FDA product code for TRU-TECH 310 ULTRASOUND THERAPY UNIT #310 is IMI.

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 Tru-Trac Therapy Products, 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.

K871633TRU-SOUND ULTRASOUND THERAPY UNIT

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.

↑