Exer Labs – FDA Warning Letter, Oct 24, 2024

On February 10, 2025, the FDA issued a Warning Letter to Exer Labs, Inc. following an inspection from October 17-24, 2024, in Denver, CO. The firm manufactures the Exer Scan, classified as a device under 21 U.S.C. § 321(h).

The Exer Scan is deemed adulterated under 21 U.S.C. § 351(f)(1)(B) because Exer Labs lacks an approved premarket approval (PMA) or investigational device exemption (IDE) application. It is also misbranded under 21 U.S.C. § 352(o) for failure to submit a 510(k) premarket notification. While devices under 21 CFR 890.5360 (Measuring Exercise Equipment) are generally exempt from premarket notification, Exer Labs markets the Exer Scan for unexempted uses, specifically employing AI-based algorithms for screening, diagnosing, and treating musculoskeletal and neurological disorders (e.g., Parkinson's, MSK, Cerebral Palsy), which goes beyond exercise measurement or rehabilitation.

The inspection also revealed the device is adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21