Devices

FDA Warns Chirp Innovations Over Unauthorized Pain Claims

FDA has issued a Warning Letter to Utah-based Chirp Innovations LLC for promoting its cleared Halo Wireless Muscle Stimulator for menstrual pain without obtaining additional marketing clearance and for widespread deficiencies in its quality system and medical device reporting procedures. The 10/2 Warning Letter followed an 11/2025 inspection of the company's Lehi, Utah facility.

FDA said the Chirp Halo Wireless Muscle Stimulator, cleared under 510(k) K241509, is authorized for temporary relief of muscle pain associated with exercise or normal household activities and for electrical stimulation of healthy muscles to improve performance. But, it said, the company also promoted the device for menstrual cramps, including claims of drug-free period pain relief.

The agency said menstrual pain represents a different condition from the muscle soreness covered by the device's clearance and constitutes a major change in intended use requiring a new 510(k) submission.

FDA also cited the company's failure to establish documented procedures for management reviews, quality audits, design controls, purchasing controls, corrective and preventive actions (CAPA), and complaint handling.

The agency additionally found that Chirp lacked adequate medical device reporting (MDR) procedures to evaluate complaints for potentially reportable adverse events. FDA said the company's vice president of product acknowledged the absence of an established MDR process.

Although Chirp submitted eight responses between December 2025 and August 2026 describing corrective actions and implementation of ISO 13485-related quality procedures, FDA said the company had not provided the underlying procedures needed to evaluate the adequacy of its corrections.

FDA also noted that although the inspection was conducted under the former Quality System Regulation, corrective actions must comply with the Quality Management System Regulation, which took effect in February.

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Revised Guidance on Drug-Delivery Device Performance Requirements

FDA Accepts Orexo NDA Resubmission for Rescue Medication