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
K070766Substantially Equivalent

Psi Bands

Psi Health Solutions, Inc., Pacific Grove CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070766 is the FDA 510(k) clearance record for PSI BANDS, cleared for Psi Health Solutions, Inc. on under FDA product code MVV (Device, Acupressure). FDA records list one 510(k) clearance for Psi Health Solutions, Inc. As of , FDA records show one recall naming K070766.

Clearance record

Decision date
Received
(128 days to decision)
Product code
MVV Device, Acupressure
Device class
Unclassified
Review panel
Unknown
Applicant
Psi Health Solutions, Inc. 606 Lighthouse Ave. #168, Pacific Grove CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MVV

Trailing 12 months

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

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