FDA product code JFB: Table, Physical Therapy, Multi Function
JFB is the FDA product code for table, physical therapy, multi function. It is a Class II device, regulated under 21 CFR 890.5880 and reviewed by the Physical Medicine panel. FDA has cleared 66 510(k) submissions under JFB, 6 in the last five years, from 45 different applicants. The average 510(k) review took 122 days (median 90); 146 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Table, Physical Therapy, Multi Function |
| Device class | Class II |
| Regulation | 21 CFR 890.5880 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JFB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 2 | 192 |
| 2022 | 1 | 109 |
| 2024 | 2 | 132 |
| 2025 | 3 | 161 |
Compare with all 510(k) review times · Search every JFB clearance
Top JFB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ceragem Co., Ltd. | 7 | 2025-07-11 |
| Slenderizers Equipment Mfg., Inc. | 7 | 1988-07-15 |
| Nuga Medical Co., Ltd. | 3 | 2024-09-12 |
| Ceragem International, Inc. | 2 | 2014-12-17 |
| Inarex Corporation | 2 | 2010-12-22 |
40 more applicants have JFB clearances. See the full list in Caduvo.
Most recent JFB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250266 | Ceragem Co., Ltd. | Ceragem Automatic Thermal Massager (CGM MB-2401) | 2025-07-11 | 162 |
| K241193 | Marzzan Lucas Jorge | AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) | 2025-01-31 | 277 |
| K243644 | Ceragem Co., Ltd. | Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) | 2025-01-08 | 43 |
| K243355 | Ceragem Co., Ltd. | Ceragem Automatic Thermal Massager (CGM-MB-1902) | 2024-11-27 | 29 |
| K240168 | Nuga Medical Co., Ltd. | N7-S | 2024-09-12 | 234 |
Recalls for JFB devices
openFDA lists no recalls for product code JFB.
Frequently asked questions
What is FDA product code JFB?
JFB is the FDA product code for table, physical therapy, multi function. It is a Class II device, regulated under 21 CFR 890.5880 and reviewed by the Physical Medicine panel.
What device class is JFB?
Class II, regulation 21 CFR 890.5880. Typical premarket route: 510(k).
How long does a 510(k) take for product code JFB?
Across 66 cleared submissions the average was 122 days from receipt to decision (median 90).
Which companies have the most JFB clearances?
Ceragem Co., Ltd. (7); Slenderizers Equipment Mfg., Inc. (7); Nuga Medical Co., Ltd. (3); Ceragem International, Inc. (2); Inarex Corporation (2).
Next steps
- Run an FDA pathway report with predicate devices for product code JFB
- Run a recall and safety report across every JFB manufacturer
- Watch product code JFB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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