510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K121123Substantially Equivalent

Biofusionary Bebe

Rocky Mountain Biosystems, Inc., Wheat Ridge CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121123 is the FDA 510(k) clearance record for BIOFUSIONARY BEBE, a class II device, cleared for Rocky Mountain Biosystems, Inc. on under FDA product code IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat). FDA records list one 510(k) clearance for Rocky Mountain Biosystems, Inc. As of , FDA records show no recalls naming K121123.

Clearance record

Decision date
Received
(696 days to decision)
Product code
IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5290
Device class
Class II
Review panel
Physical Medicine
Applicant
Rocky Mountain Biosystems, Inc. 3930 Youngfield St., Wheat Ridge CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IMJ

Trailing 12 months
2 clearances under product code IMJ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IMJ, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260