DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE— 510(k) K101889

Name: FDA 510(k) clearance K101889
Creator: U.S. Food and Drug Administration
Published: 2010-08-27

Substantially Equivalent

Pivotal Health Solutions

FDA 510(k) clearance K101889 for DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE, Substantially Equivalent on 2010-08-27. Applicant: Pivotal Health Solutions. Device class: 2.

Clearance details

Applicant: Pivotal Health Solutions
Product code: Code ITH
Device class: Class 2
Regulation: 21 CFR 890.5900
Advisory panel: Physical Medicine
Date received: 2010-07-07
Decision date: 2010-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, SD, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K101889

K-number listed on FDA's recall record

Z-2326-2024 — Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.Class II·Ongoing·Pivotal Health Solutions, Inc.·20240429

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101889.

Data sourced from openFDA. This site is unofficial and independent of the FDA.

Clearance details

Recent devices under product code ITH

More clearances from Pivotal Health Solutions

Recalls naming K101889