# FDA WARNING_LETTER - HoMedics, Incorporated - August 30, 2007

Source: https://www.keypedia.com/records/warning_letter/homedics-incorporated/31011339-8dda-43db-8374-18a33ee74c35

> FDA WARNING_LETTER for HoMedics, Incorporated on August 30, 2007. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: HoMedics, Incorporated
- Inspection Date: 2007-08-30
- Product Type: Devices
- Office Name: Detroit District Office
- Summary: The FDA issued a Warning Letter to HoMedics, Inc. on June 16, 2008, following an inspection of their Dongguan, China facility from August 27-30, 2007. The letter identifies significant violations related to marketing clearance and Quality System (QS) regulation.

HoMedics is marketing the TheraP® Deluxe Automatic Blood Pressure Monitor and Therapist Select® Massagers (with infrared heating) in the U.S. without required marketing clearance or approval. The TheraP® monitor's claim "Irregular Heartbeat Detector" constitutes a new intended use, requiring a new 510(k) submission (21 CFR § 807.81(a)(3)), making the device misbranded (Section 502(o)) and adulterated (Section 501(f)(1)(B)). The Therapist Select® Massagers are also adulterated and misbranded for lacking marketing clearance, as infrared heating devices require a 510(k) (21 CFR § 890.5500). HoMedics is instructed to immediately cease promotional claims for the TheraP® monitor.

The inspection revealed adulterated heating pads, paraffin baths, and blood pressure monitors due to non-conformity with CGMP requirements of the QS regulation (21 CFR Part 820). Violations include:
1.  Failure

## Related Officers

- [Ms.](https://www.keypedia.com/people/joanne-m-givens/7d6d17bd-5f41-4cdf-8f88-488b560f73f8)

Company: https://www.keypedia.com/companies/homedics-incorporated/4060e166-a8f8-4a83-bef4-95ce77327282

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03