Hawkins Mini-E.B.A.

FDA 510(k) K862031 · Pb Sales C/O Geller & Bozeman

Substantially Equivalent for Some Indications

510(k) numberK862031

Submission

Device name
Hawkins Mini-E.B.A.
Applicant
Pb Sales C/O Geller & Bozeman
Los Angeles, CA, US
Received
May 28, 1986
Decision date
July 14, 1986
Decision
Substantially Equivalent for Some Indications (SN)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IPF – Stimulator, Muscle, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5850
Specialty
Physical Medicine

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Questions and answers

When was Hawkins Mini-E.B.A. cleared by the FDA?

Hawkins Mini-E.B.A. (K862031) received a 510(k) decision of Substantially Equivalent for Some Indications on July 14, 1986, 47 days after the submission was received.

What is the product code of K862031?

The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.