FDA Pathway + Claims Control for Fitness & Performance Devices
The #1 way sports products accidentally become “medical devices” is through claims—recovery, rehab, pain relief, injury prevention, circulation, or therapeutic effects. We help you choose a defensible pathway (wellness vs device), keep claims aligned to evidence, and ship with compliance confidence.
Common Products We Cover
If you sell into DTC, Amazon, retail, clinics, gyms, or pro/college athletics—and you use terms like “treat,” “therapy,” “pain,” “rehab,” “recovery,” or “injury”—you’re in scope.
Recovery & Therapy Devices
- EMS/TENS, muscle stimulation, neuromuscular stimulation
- Cold/heat therapy systems, contrast therapy
- Percussive massage devices (claim-dependent)
Compression & Circulation
- Pneumatic compression / recovery boots (claim-dependent)
- Circulation/edema-related claims (high risk)
- Connected recovery systems + apps
Wearables & Performance Tech
- Wearables claiming injury prevention / rehab
- Biomechanics & balance/rehab training tools
- AI/algorithms affecting clinical/therapeutic outputs
Why Fitness Devices Get Flagged
Most enforcement risk comes from “medical” claims and implied indications—not the hardware. We focus on what regulators and marketplaces actually evaluate: labeling, website copy, ads, IFU, and the evidence story.
Claims Drift
Ads, influencers, and Amazon bullets create “treatment” claims even when your intended use is wellness.
- “Treats pain” / “reduces inflammation” / “rehab”
- Implied medical outcomes (circulation/edema)
- Before/after photos that imply treatment
Pathway Confusion
Teams build products before confirming classification, standards, and test expectations.
- Wrong assumptions about exemptions
- Missing electrical safety/EMC/software docs
- Predicate mismatch or scope misalignment
Services & Fair-Market Pricing
Transparent pricing bands based on complexity, software/connectivity, and your current documentation maturity. After a short triage call, we provide a fixed or milestone quote.
Fitness Device Pathway Triage (Wellness vs Device)
Typical range: $750–$1,950
Fast decision support to avoid expensive mistakes before you scale marketing or manufacturing.
- Claim & product positioning review (site, ads, packaging concepts)
- Preliminary classification view + risk flags
- Go/No-Go recommendations + next steps
Classification + Product Code Memo (Defensible)
Typical range: $1,950–$4,950
A written, audit-ready rationale you can use internally and with partners/investors.
- Regulatory classification analysis & rationale
- Marketing claim boundaries (what to say / avoid)
- Standards/testing implications (high-level)
Claims, Labeling & Amazon/Retail Compliance Pack
Typical range: $2,500–$7,500
Keep your growth engine (ads, PDPs, influencers) inside a claim-safe box.
- Website + PDP copy rewrite recommendations
- IFU/warnings/contraindications alignment (as applicable)
- Influencer/UGC “do/don’t” claim guide
Standards & Testing Roadmap (Bench/EMC/Biocomp/Software)
Typical range: $3,500–$12,500
A practical test plan + documentation map that labs and engineers can execute.
- Standards identification & applicability rationale
- Testing matrix + vendor-ready scope language
- Requirements traceability starter + doc checklist
Predicate & Indications Sprint (If 510(k) Likely)
Typical range: $2,500–$9,500
For products drifting into device territory: lock indications + predicate logic before spending on full builds.
- Indications/intended use framing
- Predicate shortlist + comparison framework
- Evidence plan: what you can bridge vs what you must test
510(k) Build Support (When Needed)
Typical range: $15,000–$45,000+
End-to-end drafting and eSTAR assembly support for fitness/recovery devices that require a submission.
- Device description, substantial equivalence, performance sections
- Labeling/IFU alignment + risk management integration
- AI/deficiency response support as needed
Optional Add-Ons (Common in Sports/Fitness)
Retailer / Marketplace Pack
Typical: $950–$3,500
Claims-safe PDP bullets, FAQs, imagery captions, and compliance notes for Amazon/retail onboarding.
Software/Cyber Documentation (Connected Devices)
Typical: $3,500–$18,000
Doc set planning for software, cybersecurity, SBOM, threat model, and submission-ready artifacts (scope-dependent).
Deficiency / Takedown Response
Typical: $750–$9,500
Fast gap mapping + corrective copy/labeling updates for compliance escalations or platform flags.
Note: Government fees, lab/testing fees, and certification costs are not included unless explicitly stated. We can help define vendor scopes and review lab deliverables.
How We Run These Engagements
Simple phases. Tight claim control. Documentation that stays consistent across channels.
Claims + Intended Use
We map what you’re saying today (and what influencers/ads imply) to risk and pathway exposure.
Classification Decision
We define defensible positioning: wellness boundaries or medical device pathway and requirements.
Standards & Testing Plan
We build the roadmap: standards, test matrix, doc set, and what can be bridged vs newly tested.
Labeling + Execution
We align packaging, IFU, website, ads, and marketplace content to the chosen pathway and evidence.
FAQs — Sports & Fitness Devices
When does a “fitness product” become a medical device?
Usually when your claims (explicit or implied) move into diagnosis, cure, mitigation, treatment, or prevention of disease/conditions, or when you imply therapeutic effects like pain relief, rehab, injury prevention, circulation/edema reduction, or clinical outcomes. We map your full marketing footprint (site, ads, PDPs, influencer scripts) to a claim-safe boundary.
Can I keep it “wellness” and avoid 510(k)?
Sometimes—if the intended use and claims can be constrained to non-medical, general wellness positioning and your labeling stays consistent. If your product function/claims push into a device classification, we’ll outline what’s required and how to stage it responsibly.
Do you provide lab/testing costs?
Lab/testing and certification fees are paid directly to vendors and vary by device (electrical safety/EMC, biocomp, software, etc.). We help define scopes and review reports to close gaps.
Can you review only our website + ads without touching the device?
Yes—many clients start with claims + channel compliance first (website, Amazon, paid media, influencer scripts), then expand into pathway/testing once the business case is clear.
Are these prices fixed?
They’re fair-market ranges based on typical scope. After a brief triage call, we provide a fixed quote (or milestones) depending on complexity, connectivity/software scope, and current documentation maturity.
Ready to get clarity?
If you send your product link(s), current claims/ads, and any packaging/IFU drafts, we can triage quickly and recommend the fastest defensible path.
Compliance note: This page is for informational purposes and does not constitute legal advice. Final regulatory positions depend on device design, labeling, intended use, claims, and supporting evidence.