DeviceClearance

Product code SJA— Orthopedic

ReneuRx (Neural Ice)

Classification name
Injectable For Thermal Treatment Of Musculoskeletal Pain
Device class
Class 2
Regulation
21 CFR 888.3048
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

FDA classification definition

“An injectable for thermal treatment of musculoskeletal pain is an injectable device intended to inhibit sensory nerve signaling through exchange of thermal energy (e.g., cold temperatures). The device is injected into the extraneural space of the target nerve.”

— U.S. Food and Drug Administration, device classification record for product code SJA under 21 CFR 888.3048, via openFDA

Market context for product code SJA

FDA has cleared 1 device under product code SJA, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SJA

Recent clearances under product code SJA

Data sourced from openFDA. This site is unofficial and independent of the FDA.