510(k) clearance
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)
- 510(k) number
- K261887
- Applicant
- NormaTec Industries, LP
- Decision date
- Oct 6, 2026
- Date received
- Jun 5, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- IRP
- Device type
- Massager, Powered Inflatable Tube
- Device class
- Class II
- Regulation
- 21 CFR 890.5650
- Advisory committee
- Physical Medicine
- Statement or summary
- Summary
- Third party
- N
- Location
- Watertown, MA, US