What are some popular FDA-cleared brands for penis stretching?
Executive summary
A small set of traction and implant products are commonly marketed for penile stretching or aesthetic enhancement, and several vendors explicitly claim FDA clearance or approval—most notably SizeGenetics, RestoreX, Andropeyronie/Andropenis, Rejuvall’s traction device, and surgical implants like Penuma and Himplant—though regulatory nuance and varying levels of clinical evidence matter for each claim [1] [2] [3] [4] [5] [6]. The FDA treats many devices in this space as Class II “external penile rigidity” devices with special controls and, after rule changes, some manufacturers may market products without a 510(k) premarket notification provided they follow guidance, which complicates the notion of a single uniform “FDA-cleared” registry [7].
1. SizeGenetics — a widely cited “FDA‑cleared” traction system with heavy direct marketing
SizeGenetics markets a traction device for lengthening and curvature correction and explicitly states it is “FDA‑cleared,” positioning itself as a research‑backed traction technology and a long‑standing market name in enlargement claims [1]. Independent regulatory context matters because the FDA’s external penile device guidance means products in this category are Class II devices subject to special controls and, depending on compliance pathways, may be marketed without a traditional 510(k) clearance if they meet guidance criteria [7].
2. RestoreX — positioned clinically for Peyronie’s and post‑prostatectomy rehabilitation
RestoreX is described by clinics and vendors as an FDA‑approved or -cleared adjustable traction device with clinical trials supporting use for Peyronie’s disease and prevention of post‑prostatectomy penile length loss; vendor materials emphasize a defined treatment regimen (two 30‑minute treatments daily over 12 weeks) and clinical reinforcement of effectiveness [2]. That clinical framing distinguishes RestoreX from consumer extenders by tying claims explicitly to disease treatment rather than cosmetic enlargement [2].
3. Andropeyronie/Andropenis — traction devices linked to Peyronie’s protocols and company claims
Andropeyronie (branded by Andromedical/Andropenis) markets traction devices for Peyronie’s disease and reports FDA approval and clinical testing that purportedly reduces curvature and pain and decreases collagenase cycles in published protocols; company press materials cite a Journal of Sexual Medicine study and claim measurable curvature correction in many patients [3] [8]. These vendor claims are reinforced in promotional materials but require scrutiny against independent regulatory records because marketing language—“FDA approved” or “FDA certified”—is used variably across sellers [3] [8].
4. Rejuvall and clinical‑service models that supply “FDA‑cleared” traction devices
Rejuvall Health Centers advertise customized, clinician‑delivered penile traction programs and refer to “FDA‑cleared and clinically‑proven” traction devices as part of non‑surgical lengthening offerings, framing the service as medical rather than purely consumer; their site emphasizes individualized fitting and clinical oversight [4]. Such clinic‑based models blur the line between device sales and medical services and underscore the importance of clinician assessment for safety, given historical reports of injury when users begin stretching [4].
5. Surgical implants and other devices — Penuma and Himplant as FDA‑cleared implants, not traction extenders
Separately, Penuma and Himplant are surgical implants cleared by the FDA for aesthetic penile enhancement and represent a different regulatory and risk category than traction devices; Penuma has been the subject of medical reviews and Himplant positions itself as an FDA‑cleared implant option for cosmetic enhancement [5] [6]. These products are not traction devices but are relevant to anyone weighing minimally invasive traction versus implant‑based enhancement.
6. Evidence, marketing caution, and gaps in public reporting
Clinical studies exist that support some measured gains with extenders—early trials and prospective studies report increases in stretched and flaccid length with devices such as Golden Erect and other extenders in controlled use—yet many vendor claims rely on company data or press releases rather than independent, large randomized trials, and not every popular brand is linked to an explicit FDA 510(k) record in the materials provided [9] [3]. The FDA’s Class II special controls guidance means manufacturers can market compliant devices without a 510(k) if they follow the guidance, so marketing claims of “FDA‑cleared” or “FDA‑approved” require careful verification against FDA databases and published clinical literature [7] [9].