Regulatory & Quality
Device classification, quality management, and warranty information for the Splayometer DS01.
Device Classification
| Device name | Splayometer DS01 |
|---|---|
| FDA device classification | Intended FDA classification: Class I, 21 CFR 888.1250 (Nonpowered dynamometer), 510(k) exempt. Establishment registration pending. |
| GMDN code | 33785 — Hand dynamometer/pinchmeter, electronic |
| Intended use | Clinical measurement of finger and hand extension and abduction force, for use by licensed healthcare professionals. |
Quality Management System
Metric Devices operates a Quality Management System compliant with 21 CFR Part 820 (FDA QMSR), effective June 2, 2026. The QMS governs design, production, traceability, complaint handling, and Medical Device Reporting for the Splayometer DS01.
Limited Warranty
Metric Devices warrants the Splayometer™ Digital Unit and Clinical Kit (collectively, "Product") against defects in materials and workmanship under normal use for a period of one (1) year from the original date of purchase ("Warranty Period"). This is a Limited Warranty as defined by the Magnuson-Moss Warranty Act (15 U.S.C. §§ 2301–2312). This warranty applies only to the original purchaser and is not transferable.
2. Implied Warranties
In addition to this express Limited Warranty, you have rights under implied warranties, including the implied warranty of merchantability and, where applicable, the implied warranty of fitness for a particular purpose. Under Massachusetts law (M.G.L. c. 106, § 2-316A), implied warranties cannot be disclaimed or excluded in consumer transactions, and this policy does not attempt to do so. Your implied warranty rights are fully preserved.
3. What Is Covered
During the Warranty Period, if the Product exhibits a defect in materials or workmanship under normal and intended use, Metric Devices will, at its sole discretion: repair the Product at no charge, replace the Product with a new or refurbished unit of equal or greater functionality, or issue a full refund of the original purchase price. Metric Devices maintains repair and service capabilities at its facility in Nahant, Massachusetts, and will complete warranty service within a reasonable time.
4. What Is Not Covered
This express warranty does not cover damage or malfunction resulting from:
- Misuse, abuse, neglect, or failure to follow product instructions
- Unauthorized modification, disassembly, or repair by anyone other than Metric Devices
- Accidental damage, including drops, liquid exposure, or exposure to extreme temperatures
- Normal wear and tear, including cosmetic damage that does not affect functionality
- Use of non-approved accessories, cables, or calibration equipment
- Acts of nature, power surges, or other events beyond our reasonable control
These exclusions apply to the express Limited Warranty only and do not limit your rights under implied warranties or applicable law.
5. How to Make a Warranty Claim
To initiate a warranty claim, contact Metric Devices at support@splayometer.com or via the contact page. Please have ready: your name and contact information, proof of purchase, the product serial number (located on the bottom of the device), and a description of the issue. Metric Devices will provide a Return Merchandise Authorization (RMA) number and shipping instructions. Products sent without an RMA number may be refused or returned to sender. The customer is responsible for shipping costs to Metric Devices; Metric Devices covers return shipping for all warranty-approved repairs and replacements.
6. Return Policy
If you are not satisfied with your purchase for any reason, you may return the Product within thirty (30) days of the delivery date for a full refund. To qualify: the Product must be in its original condition with all included accessories and packaging, and you must obtain an RMA number before shipping. Refunds are issued to the original payment method within 10 business days of receiving and inspecting the return. No restocking fee applies. The customer is responsible for return shipping on non-defective returns.
7. Exchanges
If you received a defective or damaged Product, contact us within 30 days of delivery and we will ship a replacement at no additional cost. Defective exchanges follow the warranty claim process described in Section 5.
8. Limitation of Liability
To the maximum extent permitted by applicable law, Metric Devices shall not be liable for any indirect, incidental, special, or consequential damages arising out of or related to the use or inability to use the Product. Except as stated above, the total liability of Metric Devices under this warranty shall not exceed the original purchase price of the Product. Nothing in this policy limits or excludes liability for personal injury caused by a defective Product.
9. Dispute Resolution
If you are dissatisfied with a warranty decision, you may request that Metric Devices escalate your claim for a second review. You also retain all rights available to you under Massachusetts law, including the Massachusetts Consumer Protection Act (M.G.L. c. 93A).
10. Your Legal Rights
This warranty gives you specific legal rights. You may also have other rights that vary by state. Massachusetts consumers have additional rights under the Uniform Commercial Code (M.G.L. c. 106) and the Massachusetts Consumer Protection Act (M.G.L. c. 93A) that cannot be waived or limited by this policy.
11. Governing Law
This warranty and return policy shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts, without regard to its conflict of laws provisions.
12. Contact Information
For warranty claims, returns, or questions about this policy: support@splayometer.com or splayometer.com/pages/contact.