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)

SOFT & STROKE

K-Number: K811782 · 1981-07-31

ApplicantPhoenix Intl. Marketing, Inc.
Decision Date1981-07-31
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SOFT & STROKE is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Intl. Marketing, Inc.. It received FDA 510(k) clearance on 1981-07-31 under 510(k) number K811782. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFT & STROKE?

SOFT & STROKE is a medical device that received FDA 510(k) clearance on 1981-07-31. The listed applicant is Phoenix Intl. Marketing, Inc.. The 510(k) number is K811782.

When did SOFT & STROKE receive FDA 510(k) clearance?

SOFT & STROKE received FDA 510(k) clearance on 1981-07-31, under 510(k) number K811782.

Who is the listed applicant for SOFT & STROKE?

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

What is the FDA product code for SOFT & STROKE?

The FDA product code for SOFT & STROKE 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

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.

K243488VMAT PROTermosaludK240358ShockPhysio Mobile (model SW3200 Basic)Shenzhen Dongdixin Technology Co., Ltd.K221865BTL-094BTL Industries, Inc.K210166Omnispec ED1000Medispec, Ltd.K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave TrtK220538DolorClast RadialE.M.S Electro Medical Systems S.A

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.

↑