E613 Pair of Support Blocks

FDA 510(k) K892699 · Rifton Equipment For the Handicapped

Substantially Equivalent

510(k) numberK892699

Submission

Device name
E613 Pair of Support Blocks
Applicant
Rifton Equipment For the Handicapped
Rifton, NY, US
Received
April 13, 1989
Decision date
May 9, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
INW – Table, Mechanical
Device class
Class I (low risk)
Regulation
21 CFR 890.3750
Specialty
Physical Medicine

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More from Med Mart, Inc.

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K921272Activity ChairINN · Traditional 04/07/1992SE
K892700E65 35 Prone StanderINW · Traditional 05/09/1989SE
K892698E655 Adjustable Abduction Block W/Hip StabilizerINW · Traditional 05/09/1989SE
K892697E653 Oblong Abduction BlockINW · Traditional 05/09/1989SE

Questions and answers

When was E613 Pair of Support Blocks cleared by the FDA?

E613 Pair of Support Blocks (K892699) received a 510(k) decision of Substantially Equivalent on May 9, 1989, 26 days after the submission was received.

What is the product code of K892699?

The FDA product code is INW – Table, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3750.