510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K952536Substantially Equivalent for Some Indications

Sono 5

Zimmer Elektromedizin GmbH, D7910 Neu-Ulm, DE / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K952536 is the FDA 510(k) clearance record for SONO 5, a class II device, cleared for Zimmer Elektromedizin GmbH on under FDA product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat). FDA records list 12 510(k) clearances for Zimmer Elektromedizin GmbH, from to . As of , FDA records show no recalls naming K952536.

Clearance record

Decision date
Received
(278 days to decision)
Product code
IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5300
Device class
Class II
Review panel
Physical Medicine
Applicant
Zimmer Elektromedizin GmbH 9 Junkersstrabe, D7910 Neu-Ulm, DE
Third party review
No

Clearances, product code IMI

Trailing 12 months

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

FDA records show no clearances under product code IMI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IMI, 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