NormaTec PCD-T and PCD-B— 510(k) K161346

Name: FDA 510(k) clearance K161346
Creator: U.S. Food and Drug Administration
Published: 2016-06-15

Substantially Equivalent

NormaTec Industries, LP

FDA 510(k) clearance K161346 for NormaTec PCD-T and PCD-B, Substantially Equivalent on 2016-06-15. Applicant: NormaTec Industries, LP. Device class: 2.

Clearance details

Applicant: NormaTec Industries, LP
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2016-05-16
Decision date: 2016-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JOW

view all

K261807 — Sequential Circulator (SC-4004-DL, SC-4008-DL)2026-09-11
K254217 — Aerloom2026-08-31
K253555 — Flexitouch® Plus Advanced Pneumatic Compression System2026-07-31
K253386 — DVT Garment2026-06-25
K250242 — Compression Therapy Device (LGT-2202DVT)2026-04-24

More clearances from NormaTec Industries, LP

view all

K251905 — Normatec Elite Hip2025-09-18
K240122 — Normatec Elite2024-03-21
K221666 — Normatec Go2022-07-14
K220217 — Normatec 32022-02-25
K183169 — Pulse 2.0, Pulse Pro 2.02018-12-27

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