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
K120783Substantially Equivalent

Able-X

Im-Able, Ltd., Palos Verdes Estates CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120783 is the FDA 510(k) clearance record for ABLE-X, a class I device, cleared for Im-Able, Ltd. on under FDA product code ION (Exerciser, Non-Measuring). FDA records list one 510(k) clearance for Im-Able, Ltd. As of , FDA records show no recalls naming K120783.

Clearance record

Decision date
Received
(97 days to decision)
Product code
ION Exerciser, Non-Measuring
Regulation
21 CFR 890.5370
Device class
Class I
Review panel
Physical Medicine
Applicant
Im-Able, Ltd. 2400 Via Carillo, Palos Verdes Estates CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ION

Trailing 12 months

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

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