Normatec 3 β
Current air-compression system; K220217 is a Class II clearance under the NormaTec Industries applicant name. [25][31]
FDA-clearedListed in current U.S. catalog; availability varies by model and market.
Irvine-based recovery and rehabilitation technology company with a mixed portfolio of FDA-cleared Normatec devices and consumer health products.
Hyperice develops recovery and movement technology for consumers, athletes and professional settings. Its portfolio spans Normatec compression, Hypervolt percussion, Venom heat and vibration, Hyperice X contrast therapy, and Vyper and Hypersphere tools. The company is headquartered in Irvine, California.
Hyperice acquired NormaTec in 2020, adding a compression-device portfolio with FDA records filed under NormaTec legal entities. Current Normatec systems have product-specific clearances; those decisions do not establish a company-wide regulatory status or extend to every Hyperice product.
The business sells directly and through retailers, with Nike also serving as a product-development and distribution partner. Its consumer availability and professional-market connections support inclusion in recovery and rehabilitation technology; athlete endorsements and commercial partnerships are separate from clinical evidence.
The four mapped Normatec records are Class II, IRP air-pressure massagers. Reviewed labeling supports temporary minor muscle-pain relief and temporary circulation increase; it is not a broad clearance for athletic performance, disease treatment or every product sold by Hyperice. Other product families require separate regulatory mapping. [31][32][25][13][7][27][23][3]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [19][15]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Current air-compression system; K220217 is a Class II clearance under the NormaTec Industries applicant name. [25][31]
FDA-clearedListed in current U.S. catalog; availability varies by model and market.
Calf-compression product with K221666 clearance. [25]
FDA-clearedListed in current U.S. catalog; availability varies by model and market.
Current Elite leg system mapped to the Normatec Elite K240122 record. [25][32]
FDA-clearedListed in current U.S. catalog; availability varies by model and market.
Current hip-compression product mapped to Normatec Elite Hip K251905. [25]
FDA-clearedListed in current U.S. catalog; availability varies by model and market.
Current percussion family includes Hypervolt 3, 3 Pro and Go 3. Exact FDA classification and exemption basis have not been established in this review. [23]
Marketed Β· regulatory scope variesListed in current U.S. catalog; availability varies by model and market.
Hot, cold and contrast-therapy family, including current X 2 knee and shoulder products. Regulatory status requires model-specific confirmation. [22]
Marketed Β· regulatory scope variesListed in current U.S. catalog; availability varies by model and market.
Vibrating roller and ball families marketed for muscle recovery and massage. [27]
Marketed Β· regulatory scope variesListed in current U.S. catalog; availability varies by model and market.
Co-developed footwear: Hyperboot combines heat and compression; Hyperslide combines cushioning, heat and vibration. No Normatec clearance is automatically extended to these products. [24][1][2]
Marketed Β· regulatory scope variesListed in current U.S. catalog; availability varies by model and market.
MVP, PCD, Pulse and prescription variants have historical FDA records. Their current marketing status and ownership/SKU continuity require confirmation; they are excluded from the current portfolio totals.
Commercial availability not establishedCurrent commercial availability not established.
Recent commercial work spans the Hypervolt 3 line, Hyperice X 2, Normatec Elite Hips and Nike collaboration products. These are commercial releases, not automatically investigational medical-device programs. Modality-level recovery research is referenced separately; a complete product-specific clinical assessment is pending. [43][2][30]
Nike introduced the heat-and-vibration recovery slide, with availability scheduled for September 29 in selected markets. Current product listings support commercial availability. [2][24]
FDA cleared K251905 under NormaTec Industries, LP. The current Hyperice catalog lists Elite Hips. [25][42]
Nike announced North American retail availability beginning May 17, 2025, through both brands and selected retail partners. [1]
Atlas Credit Partners announced a growth financing facility. Facility size does not establish the amount drawn or represent annual revenue or an equity funding total. [44]
Main Street Advisors and SC.Holdings led a round including sports organizations and athlete investors. The company announcement reported a US$700 million valuation; this is historical valuation, not revenue or current enterprise value. [48]
Acquisition adds pneumatic-compression technology and combines operations. The announcement describes a Boston operating base alongside Irvine headquarters. [45]
Accessed 10/29/2026