# NormaTec Industries, LP

- Location (FDA's records): Watertown, MA
- FDA decisions: 10 (2012–2026): 10 510(k) clearances
- Product codes: IRP (8), JOW (2)
- 510(k) review time since 2016: median 39 days, against 118 for FDA's reviews in the same codes and years (8 of 8 faster)
- Predicates its devices cite: 13 (7 its own); citations of its devices by later devices: 20 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Normatec, Inc.: 2 (https://510kreport.com/company/normatec)
- Telebrands Corp: 1 (https://510kreport.com/company/telebrands)
- Ahava Stein: 1 (https://510kreport.com/company/ahava-stein)
- Fig, LLC: 1 (https://510kreport.com/company/fig)
- Shenzhen Future Electronic Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-future-electronic)

## Firms that cite its devices most
- Xiamen Weiyou Intelligent Technology Co., Ltd.: 2 (https://510kreport.com/company/xiamen-weiyou-intelligent-technology)
- Foshan Hongfeng Co., Ltd.: 2 (https://510kreport.com/company/foshan-hongfeng)
- Xiamen Senyang Co., Ltd.: 1 (https://510kreport.com/company/xiamen-senyang)
- Shenzhen Dongjilian Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-dongjilian-electronics)
- Rapid Reboot Recovery Products, LLC: 1 (https://510kreport.com/company/rapid-reboot-recovery-products)
- Sichuan Qianii-Beoka Medical Technoiogy Lnc.: 1 (https://510kreport.com/company/sichuan-qianii-beoka-medical-technoiogy-lnc)
- Fist Assist Devices, LLC: 1 (https://510kreport.com/company/fist-assist-devices)
- Elastimed, Ltd.: 1 (https://510kreport.com/company/elastimed)

## Its most-cited devices
- K160608: NormaTec Pulse and NormaTec Pulse Pro (2016), cited by 8
- K240122: Normatec Elite (2024), cited by 3
- K183169: Pulse 2.0, Pulse Pro 2.0 (2018), cited by 3
- K220217: Normatec 3 (2022), cited by 2
- K221666: Normatec Go (2022), cited by 2
- K112890: Normatec MVP (2012), cited by 1

## Recent decisions
- K261887: Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST);Normatec Elite Heat (PRO26-TL);Normatec Elite Heat (PRO26-PH);Normatec Elite Heat (PRO26-PS);Normatec Elite Heat (PRO26-PT) (Oct 6, 2026)
- K251905: Normatec Elite Hip (Sep 18, 2025)
- K240122: Normatec Elite (Mar 21, 2024)
- K221666: Normatec Go (Jul 14, 2022)
- K220217: Normatec 3 (Feb 25, 2022)
- K183169: Pulse 2.0, Pulse Pro 2.0 (Dec 27, 2018)
- K183328: Pulse Rx 2.0, Pulse Pro Rx 2.0 (Dec 21, 2018)
- K161346: NormaTec PCD-T and PCD-B (Jun 15, 2016)

Source page: https://510kreport.com/company/normatec-industries