Swell-Relief

FDA 510(k) K855004 · D.A. Schulman, Inc.

Substantially Equivalent

510(k) numberK855004

Submission

Device name
Swell-Relief
Applicant
D.A. Schulman, Inc.
Brooklyn Park, MN, US
Received
December 13, 1985
Decision date
February 12, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DRM – Compressor, Cardiac, External
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5200
Specialty
Cardiovascular

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K883681Das Sport Pump(Tm)ILO · Traditional 09/30/1988SE
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Questions and answers

When was Swell-Relief cleared by the FDA?

Swell-Relief (K855004) received a 510(k) decision of Substantially Equivalent on February 12, 1986, 61 days after the submission was received.

What is the product code of K855004?

The FDA product code is DRM – Compressor, Cardiac, External, a Class II (moderate risk) device regulated under 21 CFR 870.5200.