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FDA 510(k)

THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES

K-Number: K950655 · 1995-03-07

ApplicantUltrassage, Inc.
Decision Date1995-03-07
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES is the device name listed in this FDA 510(k) record. The listed applicant is Ultrassage, Inc.. It received FDA 510(k) clearance on 1995-03-07 under 510(k) number K950655. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES?

THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES is a medical device that received FDA 510(k) clearance on 1995-03-07. The listed applicant is Ultrassage, Inc.. The 510(k) number is K950655.

When did THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES receive FDA 510(k) clearance?

THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES received FDA 510(k) clearance on 1995-03-07, under 510(k) number K950655.

Who is the listed applicant for THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES?

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

What is the FDA product code for THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES?

The FDA product code for THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES is ISA.

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 Ultrassage, 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.

K950400HAND MASSAGE UNIT

Related Devices (Code: ISA)

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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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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