510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111279Substantially Equivalent

Nexwave Combo Muscle Stimulator System

Altivera Medical, Inc., Lone Tree CO / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K111279 is the FDA 510(k) clearance record for NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM, a class II device, cleared for Zynex Medical, Inc. on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list 5 510(k) clearances for Altivera Medical, Inc., from to . As of , FDA records show no recalls naming K111279.

Clearance record

Decision date
Received
(138 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Zynex Medical, Inc. 9990 Park Meadows Dr., Lone Tree CO
510(k) summary
Statement
Third party review
No

Clearances, product code IPF

Trailing 12 months
3 clearances under product code IPF in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IPF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20262
July 20260
August 20260
September 20260
October 20260