FDA applicant
Fairform Mfg., Co., Ltd.
FDA records 13 decisions for Fairform Mfg., Co., Ltd. (San Po Kong, Kowloon, HK) from 1991 to 1994: 13 510(k) clearances. Most are in product codes IRO (Vibrator, Therapeutic) and ISA (Massager, Therapeutic, Electric). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Fairform Mfg., Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Fairform Mfg., Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Fairform Mfg., Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report