Flexion Distraction Table

FDA 510(k) K933622 · Spinalight, Inc.

Substantially Equivalent

510(k) numberK933622

Submission

Device name
Flexion Distraction Table
Applicant
Spinalight, Inc.
Woodstock, GA, US
Received
July 19, 1993
Decision date
January 7, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
INQ – Table, Powered
Device class
Class I (low risk)
Regulation
21 CFR 890.3760
Specialty
Physical Medicine

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K960332Cardon Physical Therapy Table Model R28598INQ · Traditional Cardon Rehabilitation Products, Inc.02/13/1996SE
K960196Tri W-G, Inc Table, Tilt/Exam/Treatment Model 777INQ · Traditional Tri W-G, Inc.02/07/1996SE
K953621EVT-3300INQ · Traditional U.S. Table, Inc.11/14/1995SE
K953622PTT 6200 Elevation Therapy TableINQ · Traditional U.S. Table, Inc.09/11/1995SE
K952357The Hill Adjustable Podiatry ModelINQ · Traditional Hill Laboratories Co.07/06/1995SE
K951419Flex D-4000INQ · Traditional U.S. Table, Inc.06/30/1995SE
K952600EVT-5000BXINQ · Traditional U.S. Table, Inc.06/22/1995SE
K952359The Hill Adjustable HA90CINQ · Traditional Hill Laboratories Co.06/22/1995SE

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K946258Model 8000 Atlas C-1 Orthogonal Adjusting InstrumentLXM · Traditional 11/20/1995SE
K945954Models 4100 and 4300 MultitherapyJFB · Traditional 01/19/1995SE
K933621Hilo TableINQ · Traditional 01/07/1994SE

Questions and answers

When was Flexion Distraction Table cleared by the FDA?

Flexion Distraction Table (K933622) received a 510(k) decision of Substantially Equivalent on January 7, 1994, 172 days after the submission was received.

What is the product code of K933622?

The FDA product code is INQ – Table, Powered, a Class I (low risk) device regulated under 21 CFR 890.3760.