NormaTec
Normatec Elite Hip is an air-pressure massager intended to temporarily relieve minor muscle aches or pains and temporarily increase circulation in treated areas. The filing describes an…
Normatec Elite Hip is an air-pressure massager intended to temporarily relieve minor muscle aches or pains and temporarily increase circulation in treated areas.
The filing describes an inflatable pressure cuff that simulates manual kneading and stroking of tissues.
Listed Item
Normatec Elite standard leg system is a powered air pressure inflatable tube massager. It is intended to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas.
Controls
Buttons and a small display control treatment start and stop, time, pressure intensity and zone selection. Bluetooth also allows control through a compatible phone app. The device can also use an internal lithium-ion battery.
Who Else Makes It
Concentrated in Guangdong (17), Fujian (10), Zhejiang (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Shenzhen Yicai Health Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Zhangzhou Easepal Innovation Co., Ltd. | Zhangzhou | Fujian | Contract manufacturer | 7 |
| Grandway Technology (Shenzhen) Limited | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Shanghai Youwen Medical Technology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 2 |
| Ryder Electronics (Xinfeng) Ltd. | Ganzhou | Jiangxi | Contract manufacturer | 1 |
| Foshan Hongfeng Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 24 |
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Fofo Medical Co., Ltd. | Xiamen | Fujian | Exporter | 18 |
| Shenzhen Ruiyi Business Technology Co., Ltd. | Shenzhen | Guangdong | Specification developer | 13 |
Showing 12 of 37. All 37 manufacturers in China registered for Massager, Powered Inflatable Tube
Record
| Listed by | Normatec Industries, LP, United States |
|---|---|
| FDA product code | IRP |
| Device type | Massager, Powered Inflatable Tube |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5650 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K251905 |
| Record published | 2025-09-26 |
| Record revised | 2024-05-31 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NEH-25 | In distribution | |
| Normatec Elite/JPN11-ST | Standard | In distribution |
| Normatec 3 Leg Attachment – Tall Power (Pair)/REJ6 | In distribution | |
| Normatec 3 Leg Attachment – Short (Single)/REJ6 | In distribution | |
| Normatec 3 Hose Attachment / REJ6 | In distribution | |
| Normatec 3 Leg Attachment – Standard (Pair)/ REJ6 | In distribution | |
| Normatec Elite/JPN11-SH | Short | In distribution |
| Normatec 3 Leg Attachment – Short (Pair)/ REJ6 | In distribution | |
| Normatec 3 Leg Attachment – Standard Power (Single)/REJ6 | In distribution | |
| Normatec 3 Leg Attachment – Short Power (Single)/REJ6 | In distribution | |
| Normatec Go/ ALJ7/ Calf Wrap | In distribution | |
| Normatec 3 Leg Attachment – Short Power (Pair) | In distribution | |
| Normatec 3 Leg Attachment – Standard Power (Pair)/REJ6 | In distribution | |
| Normatec Elite/JPN11-TL | Tall | In distribution |
| REJ6 | In distribution | |
| Normatec 3 / REJ6 / Leg System | In distribution | |
| Normatec 3 Leg Attachment – Tall Power (Single)/ REJ6 | In distribution | |
| Normatec 3/REJ6/Leg System | In distribution | |
| Normatec 3/REJ6 Hip Attachment | In distribution | |
| Normatec 3 Leg Attachment – Standard (Single)/REJ6 | In distribution | |
| Normatec 3 Arm Attachment (Pair)/REJ 6 | In distribution | |
| Normatec 3 Arm Attachment/REJ 6 | In distribution | |
| Normatec 3 Right Arm Attachment/REJ6 | In distribution | |
| Normatec 3/REJ6/Control Unit Basics | In distribution | |
| Normatec 3 Leg Attachment – Tall (Pair)/ REJ6 | In distribution | |
| Normatec 3 Leg Attachment – Tall (Single)/REJ6 | In distribution | |
| Normatec Go/ALJ7/Calf Wrap Single | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LF900 | Daesung Maref Co., Ltd. | 69 |
| LX9max | Daesung Maref Co., Ltd. | 47 |
| Game Ready | Avanos Medical, Inc. | 34 |
| Compressible Limb Therapy System(LX7(V7)) | Daesung Maref Co., Ltd. | 30 |
| VU | Xiamen Weiyou Intelligent Technology Co., Ltd. | 28 |
| SP-2000 | Daesung Maref Co., Ltd. | 23 |
| BioTab | Vive Health LLC | 23 |
| Rapid Reboot | Rapid Reboot Recovery Products | 22 |
| 4 chamber sleeve | Daesung Maref Co., Ltd. | 21 |
| SP-1000 | Daesung Maref Co., Ltd. | 19 |
| Homedics | FKA Distributing Co., LLC | 18 |
| CoreTech | Vive Health LLC | 17 |
Showing 12 of 230. All products under Massager, Powered Inflatable Tube
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251905 | 2025-09-18 |
| K240122 | 2024-03-21 |
| K221666 | 2022-07-14 |
| K220217 | 2022-02-25 |
| K183169 | 2018-12-27 |
| K160608 | 2016-04-13 |
| K112890 | 2012-01-04 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.