510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070541Substantially Equivalent

Ivivi Sofpulse, Models 912-M10, Roma3 and Torino II

Ivivi Technologies, Inc., Northvale NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070541 is the FDA 510(k) clearance record for IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II, a class II device, cleared for Ivivi Technologies, Inc. on under FDA product code ILX (Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat). FDA records list one 510(k) clearance for Ivivi Technologies, Inc. As of , FDA records show no recalls naming K070541.

Clearance record

Decision date
Received
(654 days to decision)
Product code
ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5290
Device class
Class II
Review panel
Physical Medicine
Applicant
Ivivi Technologies, Inc. 224 Pegasus Ave., Northvale NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ILX

Trailing 12 months

FDA records hold no clearances under product code ILX in the trailing twelve months.

FDA records show no clearances under product code ILX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ILX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260