FDA-Device2019-08-07Class II
Maximum Pelvic Trainer (MPT)
Ralston Group
Hazard
The device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left on the market. Additionally, the firm did not submit a 510k for the device.
Sold states
Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and PR.
Affected count
534 units
Manufactured in
656 Lake Lanier Rd, N/A, Selma, AL, United States
Products
Maximum Pelvic Trainer (MPT)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2087-2019Don't want to check this manually?
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