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FDA 510(k)

SWELL-RELIEF

K-Number: K855004 · 1986-02-12

ApplicantD.A. Schulman, Inc.
Decision Date1986-02-12
Product CodeDRM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SWELL-RELIEF is the device name listed in this FDA 510(k) record. The listed applicant is D.A. Schulman, Inc.. It received FDA 510(k) clearance on 1986-02-12 under 510(k) number K855004. The device is classified under product code DRM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWELL-RELIEF?

SWELL-RELIEF is a medical device that received FDA 510(k) clearance on 1986-02-12. The listed applicant is D.A. Schulman, Inc.. The 510(k) number is K855004.

When did SWELL-RELIEF receive FDA 510(k) clearance?

SWELL-RELIEF received FDA 510(k) clearance on 1986-02-12, under 510(k) number K855004.

Who is the listed applicant for SWELL-RELIEF?

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

What is the FDA product code for SWELL-RELIEF?

The FDA product code for SWELL-RELIEF is DRM.

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.

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Other records listing D.A. Schulman, 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.

K883681DAS SPORT PUMP(TM)K872739SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHIONK831247SAFE-SEAT WHEELCHAIR CUSHION

Related Devices (Code: DRM)

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.

K221700AutoPulse NXT Resuscitation SystemZoll Circulation, Inc.K211289RMU-2000 Automated Chest Compression SystemDefibtech, LLCK173553LUCAS 3 Chest Compression SystemJolife ABK161768LUCAS 3 Chest Compression SystemJolife ABK153628ROSC-U Mini Chest Compressor (RMCC)Resuscitation International, LLCK112998AUTOPULSE RESUSCITATION SYSTEM MODEL 1000Zoll Circulation

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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