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FDA 510(k)

PROTEAM CUSHION

K-Number: K953352 · 1995-11-29

ApplicantIskra.Med
Decision Date1995-11-29
Product CodeKIC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PROTEAM CUSHION is the device name listed in this FDA 510(k) record. The listed applicant is Iskra.Med. It received FDA 510(k) clearance on 1995-11-29 under 510(k) number K953352. The device is classified under product code KIC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTEAM CUSHION?

PROTEAM CUSHION is a medical device that received FDA 510(k) clearance on 1995-11-29. The listed applicant is Iskra.Med. The 510(k) number is K953352.

When did PROTEAM CUSHION receive FDA 510(k) clearance?

PROTEAM CUSHION received FDA 510(k) clearance on 1995-11-29, under 510(k) number K953352.

Who is the listed applicant for PROTEAM CUSHION?

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

What is the FDA product code for PROTEAM CUSHION?

The FDA product code for PROTEAM CUSHION is KIC.

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: KIC)

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.

K960189GEL-T CUSHIONSpan-America Medical Systems, Inc.K954117CUSTOMCARE SEATING SYSTEMSpan-America Medical Systems, Inc.K950085MULTICURE(R) S GEL PADMultigestion (Deutschland) GmbHK945667MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHIONMicos Medical SystemsK941858GEL CUSHIONHollister, Inc.K911843ZERO-G(TM) GEL/FOAM MATTRESS TOPPERSteridyne Corp.

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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