Normatec Elite Heat (6 models)— 510(k) K261887
Substantially EquivalentNormaTec Industries, LP
FDA 510(k) clearance K261887 for Normatec Elite Heat (6 models), Substantially Equivalent on 2026-10-06. Applicant: NormaTec Industries, LP. Device class: 2.
Summary
Normatec Elite Heat from NormaTec Industries is cleared in six models, PRO26-SH, PRO26-ST, PRO26-TL, PRO26-PH, PRO26-PS, and PRO26-PT. Product code IRP is powered inflatable tube massagers. The record doesn't explain the model suffixes.
Class II, 21 CFR 890.5650. The Physical Medicine panel reviewed it as a Traditional 510(k).
NormaTec filed from Watertown, Massachusetts. Review took 123 days (June 5 to October 6, 2026).
Clearance details
- Device name as filed
- 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)
- Applicant
- NormaTec Industries, LP
- Product code
- Product code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Watertown, MA, US
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