FDA product code IRP: Massager, Powered Inflatable Tube
IRP is the FDA product code for massager, powered inflatable tube. It is a Class II device, regulated under 21 CFR 890.5650 and reviewed by the Physical Medicine panel. FDA has cleared 156 510(k) submissions under IRP, 59 in the last five years, from 97 different applicants. The average 510(k) review took 154 days (median 116); 164 days on average over the last three years. FDA has posted 5 recalls for IRP devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Massager, Powered Inflatable Tube |
| Device class | Class II |
| Regulation | 21 CFR 890.5650 |
| 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 IRP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 189 |
| 2018 | 3 | 72 |
| 2019 | 10 | 144 |
| 2020 | 9 | 145 |
| 2021 | 19 | 204 |
| 2022 | 14 | 155 |
| 2023 | 10 | 165 |
| 2024 | 12 | 154 |
| 2025 | 13 | 145 |
| 2026 | 10 | 194 |
Compare with all 510(k) review times · Search every IRP clearance
Top IRP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Daesung Maref Co., Ltd. | 8 | 2023-07-19 |
| Xiamen Weiyou Intelligent Technology Co., Ltd. | 7 | 2026-06-10 |
| NormaTec Industries, LP | 7 | 2025-09-18 |
| Mego Afek AC , Ltd. | 6 | 2019-05-15 |
| Wonjin Mulsan Co., Ltd. | 5 | 2021-09-14 |
92 more applicants have IRP clearances. See the full list in Caduvo.
Most recent IRP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260944 | Manamed, LLC | ManaCold Compression System | 2026-08-12 | 142 |
| K260529 | Xiamen High Top Electronic Technology Co., Ltd. | Air Compression Massager (HY-1165) | 2026-07-27 | 160 |
| K260948 | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. | Air Compression Massager (EP30B001 I) | 2026-07-24 | 123 |
| K253919 | Xiamen Weiyou Intelligent Technology Co., Ltd. | Cryo And Thermo Therapy System | 2026-06-10 | 184 |
| K252396 | Avanutri Equipamentos DE Saúde | Cryo Sport 2.0 (AVA 501) | 2026-05-29 | 302 |
Recalls for IRP devices
5 product recalls in 4 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-01-17.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2023 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code IRP?
IRP is the FDA product code for massager, powered inflatable tube. It is a Class II device, regulated under 21 CFR 890.5650 and reviewed by the Physical Medicine panel.
What device class is IRP?
Class II, regulation 21 CFR 890.5650. Typical premarket route: 510(k).
How long does a 510(k) take for product code IRP?
Across 156 cleared submissions the average was 154 days from receipt to decision (median 116).
Which companies have the most IRP clearances?
Daesung Maref Co., Ltd. (8); Xiamen Weiyou Intelligent Technology Co., Ltd. (7); NormaTec Industries, LP (7); Mego Afek AC , Ltd. (6); Wonjin Mulsan Co., Ltd. (5).
Have IRP devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2025-01-17.
Next steps
- Run an FDA pathway report with predicate devices for product code IRP
- Run a recall and safety report across every IRP manufacturer
- Watch product code IRP 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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