Proact 1
FDA 510(k) K003909 · Proact Co.
510(k) numberK003909
Submission
- Device name
- Proact 1
- Applicant
- Proact Co.
Mt Pleasant, SC, US - Received
- December 19, 2000
- Decision date
- June 13, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IRP – Massager, Powered Inflatable Tube
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5650
- Specialty
- Physical Medicine
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| K253076 | Cryopush Cold Compression Device (A02-P-001)IRP · Traditional | Chengdu Cryo-Push Medical Technology Co.,Ltd | 04/02/2026SE |
| K251622 | Hand Massager (SM004D)IRP · Traditional | Ningbo Zhenhai Yihao Electronic Technology Co.… | 01/28/2026SE |
More from Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K052243 | Proact with Gel or Proact 1JOW · Traditional | 04/12/2006SE |
| K941256 | Quick Core IIKNW · Traditional | 07/13/1994SE |
| K926559 | Proact Biopsy Needle EnchancementsFCG · Traditional | 03/22/1993SE |
| K913306 | Bone-Temno/Sternum-TemnoLWE · Traditional | 11/01/1991SE |
| K902320 | Bauer Flexi-Temno Biopsy NeedleFCG · Traditional | 10/01/1990SE |
| K902319 | Bauer Temno Biopsy NeedleFCG · Traditional | 09/06/1990SE |
Questions and answers
When was Proact 1 cleared by the FDA?
Proact 1 (K003909) received a 510(k) decision of Substantially Equivalent on June 13, 2001, 176 days after the submission was received.
What is the product code of K003909?
The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.