FDA 510(k)

MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT

K-Number: K861864 · 1986-07-14

Decision Date1986-07-14

Product CodeIMJ

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is I-Rep, Inc.. It received FDA 510(k) clearance on 1986-07-14 under 510(k) number K861864. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT?

MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT is a medical device that received FDA 510(k) clearance on 1986-07-14. The listed applicant is I-Rep, Inc.. The 510(k) number is K861864.

When did MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT receive FDA 510(k) clearance?

MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT received FDA 510(k) clearance on 1986-07-14, under 510(k) number K861864.

Who is the listed applicant for MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT?

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

What is the FDA product code for MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT?

The FDA product code for MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT is IMJ.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing I-Rep, Inc. as applicant

K930692LATHAM TABLE K930691ACCUTRAC TRACTION UNIT K854947REHABILITATION TABLES K851690ADJUSTABLE TREATMENT TABLES K842268VACUPULSE VACUUM UNIT K832940ROTAGYM

View all 8 devices →

Related Devices (Code: IMJ)

K252963BTL-899TTBTL Industries, Inc.K250376ViVYViatherm Therapeutics, LLC K243112Curapuls 670Enraf-Nonius, B.V.K223620Reprieve by RegenesisTMRegenesis Biomedical, Inc.K182363BTL-703BTL Industries, Inc.K173300ViaTherm BOOSTViatherm Therapeutics, LLC

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.