Fairform Mfg., Co., Ltd.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Fairform Mfg., Co., Ltd.” (first 1991, latest 1994), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 52 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IRO | Vibrator, Therapeutic | 11 | 11 |
| ISA | Massager, Therapeutic, Electric | 1 | 1 |
| JEQ | Toothbrush, Powered | 1 | 1 |
Review panels
- Physical Medicine (12)
- Dental (1)
Most recent Fairform Mfg., Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931640 | AO11 BODY MASSAGER | IRO | 1994-03-28 | 362 |
| K931639 | F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR | IRO | 1994-03-28 | 363 |
| K931638 | FO96 HANDY MASSAGER | IRO | 1994-03-28 | 362 |
| K931637 | A013 FEMI-FORM FACIAL MASSAGER | IRO | 1994-03-28 | 362 |
| K931636 | FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER | ISA | 1994-03-28 | 362 |
| K920644 | F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND | JEQ | 1992-05-29 | 107 |
| K914830 | A101 LITESSAGER | IRO | 1991-12-09 | 45 |
| K914829 | FO92 SEATING MASSAGER | IRO | 1991-12-09 | 45 |
| K914707 | F055 B.O. FANTASTIC RELAXER | IRO | 1991-12-09 | 52 |
| K914706 | FO51/F151 GOLF MASSAGER | IRO | 1991-12-09 | 52 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Fairform Mfg., Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Fairform Mfg., Co., Ltd.?
FDA lists 13 510(k) clearances under the applicant name “Fairform Mfg., Co., Ltd.” (first 1991, latest 1994), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fairform Mfg., Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fairform Mfg., Co., Ltd. is 52 days.
Which FDA product codes appear under Fairform Mfg., Co., Ltd.?
The most frequent FDA product codes under this applicant name are IRO (Vibrator, Therapeutic, 11); ISA (Massager, Therapeutic, Electric, 1); JEQ (Toothbrush, Powered, 1).
Next steps
- See all 13 Fairform Mfg., Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IRO, Fairform Mfg., Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.